The Challenge

A privately owned, rapidly growing pharmaceutical company was charged with rolling out 22 releases for a multi-product launch in one year’s time. In the early stages of the program, the client struggled with a series of issues that, if not corrected, would ripple through the subsequent launches. While each release had a project manager, they lacked a dedicated resource who could manage the program at a strategic level to ensure alignment with business use cases, communicate with IT and ensure the overall success of the interconnected projects. The client turned to CMK to correct the inefficiencies observed and offer a more methodical approach to the overall program.

The Solution

The CMK team began by assigning a program manager to oversee the portfolio of projects and provide strategic direction in support of business goals. They built a formal Agile team with clearly defined roles and responsibilities, established a new meeting cadence that made better use of the team’s time, streamlined communication with the project teams and stakeholders and created templates that support a more prescriptive approach. With trust established, the client later turned over the financial management and reporting responsibilities to CMK.

The Results

Since bringing CMK on board to manage the program, the client seamlessly launched three releases over the course of three months—on time and on budget. With repeatable processes and protocols now in place, they are currently on pace to complete the remaining 16 launches by year-end.

The Challenge

The U.S. cardiovascular team of a global pharmaceutical company needed help responding to a new Corporate Integrity Agreement for two launch products. Resource-constrained at the time, they were looking for a streamlined and efficient way to satisfy the strict government-imposed deadlines without blowing their budget or delaying the products’ launch dates. The client turned to their trusted partners at CMK for strategic guidance and support in addressing this immediate need.

The Solution

The CMK team began by exploring creative ways to use the client’s existing procedures and compliance and regulatory documentation to meet the new requirements while delivering long-term efficiencies. They made process improvement recommendations, built templates, created guidance documents and defined a more streamlined approach for meeting deliverables more efficiently. In collaboration with the client’s key stakeholders, the CMK team then developed planning documents and configured them to perform automated tracking and reporting around tactics, budgets, priority, business case, changes, timing, dependencies and more.

The Results

With newly streamlined procedures and enhanced documentation in place, the additional checkpoints were implemented on time and did not impact the client’s budget or launch timelines. The tracking and reporting functionality allows the project teams to have more meaningful, data-backed discussions with stakeholders, while the automation capabilities make it easy to uncover areas of opportunity and track progress for continuous improvement. Today, the client is equipped with repeatable processes that help them ensure ongoing compliance with all policies and procedures and transparency with internal and external constituents—and also serve as a best-practice that can be shared across other therapeutic areas.

The Challenge

Within hematology, Higher Risk-Myelodysplastic Syndrome (HR-MDS) and Acute Myeloid Leukemia (AML) are diseases with a highly unmet treatment need. In response, an NJ-based pharmaceutical leader created an innovative new immune-modulating treatment that shows tremendous promise in the fight against myeloid disease.

While the new regimen offered an effective immunotherapeutic approach that addresses the lack of durable response in myeloid disease, aided and unaided awareness of the treatment among practitioners was very low—around 10%. The pharma giant turned to CMK to create a program designed to drive awareness and generate excitement about the new drug in advance of its launch.

The Solution

CMK implemented a multi-pronged Disease Awareness Campaign aimed at delivering key messages to practitioners through multiple channels. They created a highly engaging website to house all pertinent information about the disease itself, treatment limitations and the drug’s mechanism in the body, followed by a robust media campaign that included banner ads, emails, paid search, videos and social media marketing.

The Results

Within six months, awareness soared to 60%, with total hits to the site approaching 20K. Today, the client is on pace to reach its goal of 80 – 100% aided awareness by the end of the year for what is expected to become the cornerstone of treatment for MDS/AML.

The Challenge

When two large pharmaceutical companies merged, the study teams struggled with a lack of clarity over which operating models to follow for their respective studies. With heritage procedures and IT systems in place across both entities, and pros and cons to each depending on the lifecycle management processes at play, the client needed a way to define, streamline and integrate each disparate component for more efficient, audit-ready processes and protocols.

The Solution

CMK worked with the client to coordinate, compile and evaluate every operating model currently in use. They identified best practices and devised a mixed-models approach that assigned a specific operating model to each of the multiple processes. Recognizing the need for a central repository to house all pertinent information, CMK also partnered with key stakeholders to collect procedural documents and resources for every process, with source links to each respective system.

The Results

With the operating models and related IT systems defined and a single policy portal system that offers one version of the truth, the study team is well equipped to execute trials efficiently and without confusion. And with inspection-ready standard operating procedures in place, the team can quickly and easily respond to compliance inquiries.

Project management challenges exist at all levels of the organization—from the highest strategic level down to the project task level. In today’s business environment, an organization’s ability to recognize and resolve those challenges is a crucial driver in enhancing business performance for greater stability and sustained growth.

Here are the top 5 project management challenges that organizations face today:

Challenge 1: Managing Conflicts 

The Problem – A project, by definition, is a one-time activity that generally includes cross-functional or cross-divisional engagements. Conflict is a natural byproduct of any project, given the added stress associated with tight budgets, firm deadlines and conflicting interests of stakeholders. That’s not necessarily a bad thing; some degree of conflict can be energizing and inspire innovation. But there is a threshold that, when crossed, turns constructive conflict into destructive conflict.

The Solution – Consider hosting a series of collaborative workshop sessions to identify the root of the conflict, identify common views, brainstorm ideas and come to agreeable solutions that will move the project forward. Another approach would be to engage an objective third-party, such as a manager or a trusted expert in the field (e.g., an IT expert for tech-related issues), to present additional options.

Challenge 2: Sponsorship Involvement

The Problem – Sponsorship challenges can take on a range of forms—from too little involvement to too much. According to a PMI Pulse of the Profession Report, the top driver of a project’s success in meeting its goals and intent is an actively engaged executive sponsor.¹ Project sponsors are there to remove obstacles and support an efficient project flow. An absentee sponsor is likely too distracted to remove those obstacles, while a micro-managing sponsor may end up creating more. Both ends of the spectrum affect project success.

The Solution – Form a steering committee at the onset of the project, with clearly defined roles and responsibilities. With input from the steering committee members, create an organizational communication strategy that outlines how communications will be shared across the various levels and stakeholders. Assign a high-level strategic advisor to work with the steering committee to ensure ongoing alignment to the vision and communication strategies and measure ongoing success.

Challenge 3: The Project and Methodology Don’t Fit

The Problem – Different projects require different methodologies. All too often, the methodology being used doesn’t support the project requirements and goals. This might occur if there is no established methodology within the organization, requiring the project team to reinvent the wheel with each project. Or maybe your organization does have a robust methodology in place, but it is too rigid to handle the variety and scope of projects that arise. The wrong methodology can render the project inexecutable.

The Solution – The most effective way to address this common problem is to engage in training that covers project management methodologies (e.g., Agile or Waterfall). If your organization does not already have one, establish a methodology that can be applied to the various types of projects your organization encounters. Next, create an accompanying set of processes and tools, with guidance on how to implement them across a range of projects. Include a decision tree or matrix to ensure the right tools and processes are being used on the right types of projects.

Challenge 4: Priority and Portfolio Management

The Problem – Most organizations have dozens of initiatives that are considered essential to business success. But with limited human capital resources and budgetary constraints, they can’t all be addressed, leaving business leaders in a state of analysis paralysis in determining project priority. Priority challenges can also arise when a new, previously unplanned project emerges that warrants shifting resources that were already allocated to existing projects. Without a structural way of evaluating priority across a portfolio of projects, business leaders struggle to ensure they’re making the right decisions that will maximize their investment.

The Solution – Adopt a project portfolio management discipline that achieves the following objectives:

• Aligns projects with the overall business strategy
• Offers a sound governance process to analyze and approve projects
• Manages the supply vs. demand or capability vs. capacity of the organization
• Manages portfolio performance across the slate of projects

Challenge 5: Managing Complex Programs with Multiple Moving Parts 

The Problem – Programs that include a slate of projects aimed at achieving the same organizational objective can prove extremely complex to manage. With so many separate but interdependent moving parts, all it takes is a breakdown in one area to negatively impact the whole program. Without a structured, methodical way to organize the endeavors across teams and departments, many organizations fall short of strategically executing the program.

The Solution – Adopt a program management approach that manages interdependencies across the projects at the program level. Here, you’ll be able to achieve economies of scale and scope, find synergies and facilitate efficient project workflows across the program. For example, you can manage resources at the program level, rather than at the project level, while ensuring each project is aligned with the strategy.

With a continued focus on project management excellence and a cohesive approach to resolving challenges as they arise, an organization will be poised for enterprise-wide success. For help resolving your most pressing project management challenges, call us today.

CMK Select is pleased to announced that it has been recognized by NJBIZ as a finalist for 2020 Business of the Year. Each year, NJBIZ recognizes the state’s most dynamic businesses and business leaders who share a commitment to professional excellence, business growth and the community. This year, CMK Select was one of seven finalists in the Business of the Year category for companies with 51-100 employees.

Only businesses that have made a significant impact on the New Jersey business community are considered for the award each year. In 2020, during one of the most tumultuous periods in recent history, CMK seamlessly adopted a shift in mindset, as well as a series of new technologies and innovative communication strategies, to support its customers and address the challenges those customers faced in the new environment. Over the course of the pandemic, CMK has rebuilt its operations to enhance the value that it provides to its clients – and has done so with zero disruption to the business or its clients.

Joining CMK in its Business of the Year finalist category are Clarity Benefit Solutions, Docutrend Imaging Solutions, Fusion Health, Learning Ally, March Associates Construction Inc., and WeCool Toys Inc.

CMK Select is business with extensive expertise in medical affairs, commercial, business technology and compliance, and has been delivering superior program and project management to clients in the life sciences industry for nearly 15 years.

NJBIZ, New Jersey’s leading business journal, produces a weekly print edition with a circulation of more than 15,000 copies, as well as providing 24/7 business news coverage through its NJBIZ.com website and multiple daily e-newsletters. In addition to Business of Year (which is awarded to businesses in three categories: 1-50 employees, 51-100 employees, and 101+ employees), NJBIZ also annually recognizes Corporate Citizen of the Year, Emerging Business of the Year, and Executive of the Year.

According to the PMI’s 2020 Pulse of the Profession, the average project wastes nearly 11.4% of its funding. Organizations that undervalue project management as a strategic competency are the hardest hit, enduring a staggering 67% project failure rate.*

Project management readiness cannot be ignored. Yet many organizations don’t know where to begin. Typically, when an organization decides it is time to explore project management training, it is usually the result of one of the following scenarios:

• A new CEO or team leader joins the company, takes an objective look at the business, and identifies a problem that needs attention to support its strategic goals.
• An organization fails to execute a particular initiative successfully, prompting a reactive evaluation of areas of opportunity and changes that must be made.
• The HR team identifies project management as a new core competency, and they need a broad-scale training program in place to level skillsets.

Without a consistent project management approach in place, project teams face greater challenges, more conflict and lower employee satisfaction. Project outcomes are adversely impacted, as well, with reduced quality and wasted time and money.

How can project management training benefit your organization?

Project management training ensures that everyone on your team employs the same basic practices, method and approach. But the benefits don’t stop there; a robust project management training program also offers wide-reaching, organizational benefits.

1. Arm your workforce with leadership skills: While members of a project team may share some basic project management skills they typically possess very different project management backgrounds and levels of understanding. By aligning your team’s understanding of essential project management skills, tools and techniques, you will enable your team to better plan projects, leverage opportunities, mitigate threats, manage change, influence others, partner with stakeholders and work with difficult people—all key leadership skills.
2. Improve collaboration: One of the most common barriers to project management success is the lack of one common language, which causes confusion and project delays. With project management training, project teams benefit from a standard lexicon that facilitates more productive conversation, better collaboration and improved awareness across teams. Open channels of communication foster better cross-functional teamwork with quicker response and turnaround times—a practice that can be applied to the everyday workplace.
3. Boost profitability: With an organized project management methodology, your project teams can plan more efficiently, spot potentially costly issues before they become a problem, prioritize goals and allocate resources more appropriately. Equipped with these foundational skills, your teams will be able to deliver higher quality results with fewer resources—on budget, on schedule and within scope—for markedly improved profitability.

Project Management training not only offers a systematic approach to managing and controlling different types of projects – it also equips employees with portable knowledge, skills, tools and techniques they can apply in the day-to-day work environment—ultimately enabling them to add greater value to the business. To learn more about our Project Management training services, contact us today.

* https://www.pmi.org/learning/library/forging-future-focused-culture-11908

In a recent article, Risk Management and Disaster Recovery in the Age of COVID-19, we discussed how we can gain valuable risk management insights by first looking at the likelihood and impact of a given risk and then drilling down another level and assessing the likelihood and impact of each risk’s specific consequences.  In this article, we’re going to explore that concept further by putting these ideas into practice. Using a simple Risk and Consequences Excel spreadsheet (available for download at the end of this article), you will be able to identify and mitigate the hidden consequences that can severely and negatively impact your project.

For this example, let us imagine that we are planning out a product release and we are assessing what risks could impact our delivery date.  We identify three high-level risks that could have an adverse impact on our release: pandemic, flood and fire.  The table below shows our assessment of the likelihood of each risk, and it also lists out the possible consequences for each risk if they were to eventuate.  Each of those consequences assumes its own unique row, which means the Pandemic risk has four associated rows – one for each consequence identified.  Next, we look at the likelihood of each consequence occurring and the relative impact of that consequence, all assuming that the associated parent risk occurred.  Finally, we calculate the relative severity of the consequence using the following formula:

Relative severity of a risk consequence = (likelihood of the associated risk) * (likelihood of this consequence) * (impact of this consequence)

The higher the severity level of a consequence, the more important it will be to identify mitigating activities to address it.

As the example above shows, water damage to the building has the highest severity because the risk of a flood is high, the likelihood of water damage to the building is high if the flood occurs, and the consequences of water damage to the building are also high.  We can conclude that developing a mitigation plan for water damage to the building would be prudent.  This is a good start – but there is yet another layer of risk hidden in this data that merits our attention.

Consequence Analysis: Targeting the data across risk categories

Note that in this example all three of our risks include the consequence, “Staff must work from home.” The second tab of the risk mitigation log, Consequence Analysis, is a pivot table that sums up and charts the Severity of Consequence column from the first tab for each of the likely consequences.

Why is this interesting, and why is it important?

On the prior tab, “water damage to building” had the highest severity of consequence score for a specific, individual risk.

However, this tab scores the severity for consequences across all three risk categories. Imagine the aggregate score this way: If a pandemic occurs OR a flood hits OR a fire damages the building, which of my consequences is most likely to occur, and with what severity?

When adding those scores across all risk categories in the other tab, “staff must work from home” (pandemic 28.0 + flood 48.0 + fire 48.0 = 116) is designated the most likely and has the most severe impacts.  As such, this is a high priority consequence that merits mitigation. By identifying consequences that are shared across multiple risks, companies can take steps to mitigate those consequences so that when ANY of the associated risks become a reality, they know what steps to take for that consequence.  Think about companies that had proactively established mitigation plans in the event their staff needed to work from home due to a flood or a fire (much more likely risks); they looked pretty smart when a once-in-a-century pandemic hit.

This risk mitigation log is offered as a high-level stepping stone to begin the discussions for developing a risk management strategy with your key stakeholders and the executive teams. More sophisticated tools can expand on this data and show the interrelationships between certain risks, consequences and their impact and help you develop appropriate mitigation strategies.

We invite you to download this spreadsheet and start identifying and prioritizing the “big hitter” consequences of specific risks that can have serious, detrimental effects on your organization should you wake up tomorrow face-to-face with another disaster.

Our previous posts in this series reviewed the history and evolution of Medical Affairs departments in the pharma industry, noting how the growth of these departments led to an increasing need for project management expertise. We then explored the ways that project management can provide value to Medical Affairs, such as:

• Leveraging assets and maximizing budget efficiencies
• Providing creative approaches to project planning and implementation
• Serving as a communications hub and keeping stakeholders informed about project status

These and other project management activities all have the potential to help Medical Affairs deliver positive results for the organization as a whole. However, the above examples also demonstrate something else: that, even when the organization’s and the department’s overall results are positive, it may not be easy to objectively measure the value provided by a function like project management.

For example, how do we know if the manager has fully leveraged departmental assets? Is it possible to accurately judge the manager’s level of creativity in the planning process? How can we ascertain if a manager is communicating with maximum effectiveness?

Finding objective answers to these types of questions can be quite challenging. And, even in cases in which results can be quantified, it can be hard to know how much control a project manager has over specific aspects of individual outcomes.

What’s more, there are many different teams in the Medical Affairs setting, and perspectives can vary from team to team. While one group may see great value in a project manager’s efforts, others may see things differently.

Given that the perceived value of project management can be very subjective, it makes sense for Medical Affairs departments to try to use as many objective measures as possible when evaluating a manager’s performance.

An opportunity for accountability

When seeking ways to gauge the value of project management in Medical Affairs, the business case and related project plans provide benchmarks that are readily available to most teams.

The business case is the argument made at the outset of each and every project that the task is viable; that the core business benefit is worth the investment; and that the opportunity outweighs the potential risk. It is a presentation that outlines the path the organization should take to achieve that specific core benefit.

When leadership agrees that the business case is viable, it signifies the belief that the chosen path is the best of all available options. And, once the business case is accepted, a project plan is then created, offering all of the detail needed to travel down that path.

From that point, Medical Affairs project managers typically become responsible for checking that the path is being adhered to—that the plan is being followed—as rigorously as possible.

These types of plans are filled with schedules, milestones, budget projections, etc. So, if the organization wants an objective means of holding people such as the project manager accountable, project plans can provide a wealth of opportunities.

When measurement is a challenge

Schedules, milestones, budgets and other objective measures are vital when assessing the value provided by project management. But other aspects of project management can be much harder to gauge.

Take quality control. Good manufacturing practices provide objective tools to determine the quality of a product’s manufacture. Unfortunately, that kind of cut and dried quality evaluation isn’t available when considering essential, yet highly subjective, concerns such as the satisfaction levels of a department like Medical Affairs.

Experts say that team satisfaction is among the most important of all success criteria, and project managers are often responsible for managing and maintaining the satisfaction levels of internal Medical Affairs teams—and sometimes external groups as well. For example, project managers can help to ease the traditional tensions between Medical Affairs and the Commercial arm.

But how do we objectively gauge quality in those arenas? Surveys and interviews are often used to rate satisfaction, but given an environment where project managers have so many tasks involving so many teams, these tools may not be fully able to assess the quality of the manager’s performance.

Yet we can’t deny the importance of gauging satisfaction. Simply put, a project manager is unlikely to succeed if he or she is unable to satisfy the department’s teams. In this situation, leadership may have to take more of an “I know it when I see it” approach instead of using any objective measures.

It’s interesting that it’s sometimes possible to determine external levels of satisfaction—also highly important to Medical Affairs—more accurately than that of internal teams. And, in many cases, external customer satisfaction can be generally reflective of a project manager’s effectiveness.

For Medical Affairs, external customers include the product adopters (providers, payers and patients), so we can use product utilization as one measure of their satisfaction. However, even this gauge may not always be reliable. What if the product is well-utilized in markets where organizational communication is highly effective, but is poorly accepted by audiences we have trouble reaching? Is the problem with the product or the promotion? Or is there another intervening issue entirely—a high amount of competition in that market, for example?

Living with uncertainty

The reality is that all clinical projects contain some degree of uncertainty. Despite this fact, sometimes Medical Affairs—and specifically project management—may be faulted when circumstances are actually beyond their control. Consider recruitment-based study delays, or investigator scheduling conflicts. These obstacles can frustrate a project manager’s best attempts to meet pre-established deadlines, yet he or she may still be held accountable.

And, even when every aspect of the clinical process proceeds unimpeded, there can be disagreements within Legal, Regulatory and Compliance teams; or, when they all agree, the Commercial department may opt for a different approach.

As one Medical Affairs project manager has said, “Some things just have to be lived with,” and the planning process needs to accept the reality that uncertainty is an inevitable part of the clinical function.

Many leading organizations recognize that objective standards are hard to come by in many aspects of project management. They know that any assessment of project management’s true value should take all of these factors into account.

Clearing up the picture

Researching the value of project management in Medical Affairs leads us to see that, while objective measures should be employed whenever possible, project managers often provide significant value in less tangible ways. Project management can be more art than science, and some aspects of the project management field seem to defy measurement entirely.

We would like to offer a few of the questions organizations can ask to gain a clearer picture of project management effectiveness:

• Are the priorities set by Medical Affairs leadership being achieved, on time and on budget?
• Does the project’s progress consistently match departmental business requirements?
• Is the project manager’s performance adaptable in changing situations?
• Are shifts in departmental needs and the overall project environment being effectively anticipated and responded to?

Finally, it’s vital to keep in mind that Medical Affairs is ultimately focused on the patients’ interests. This means that, in the end, the organization’s success, the department’s success, and the project manager’s effectiveness, can really only be proven by the way the product is received by providers, payers and, most of all, by patients.

Positive results come from extensive experience

Given the complexity of the project management function in Medical Affairs, experience really counts. Over the years at CMK Select, we have managed countless pharmaceutical projects. We have met the most difficult challenges, and we have implemented tried and tested systems that consistently deliver excellent results. We are happy to share our expertise, or you can engage our highly-trained, expert staff. Either way, you and your Medical Affairs department will benefit. Contacting CMK Select will boost your success, now and in the future.

In our prior article, we discussed the history and evolution of Medical Affairs departments, and reviewed how these departments have grown to perform so many integral functions within pharmaceutical companies. We also observed that, as Medical Affairs’ work streams have multiplied over time, the need for project management expertise has increased substantially.

In general terms, project managers’ duties in Medical Affairs can be described as helping to free other members of the department to do what they do best. These managers can be tasked with everything from streamlining the work, increasing efficiencies, and overcoming or eliminating obstacles, to anticipating and solving problems, and controlling or reducing costs.

While this may sound demanding, it makes sense when we consider the extensive and essential service that Medical Affairs provides within pharma.

Dealing with complex challenges

Project management in Medical Affairs is complex and challenging work. Project managers are asked to handle dozens of competing demands, required to deal with a myriad of priorities, and they must build and maintain relationships with dozens of individuals at varying levels of authority, both internally and outside the company. Also, project managers typically are asked to meet very specific departmental expectations, yet those expectations can differ significantly from those of the company at large.

And, of course, they must manage within Medical Affairs schedules, which tend to be very tight.

In many cases, departmental budgets can be even tighter.

While maneuvering through this stress-inducing landscape, project managers are also counted on to smoothly and capably accomplish such essential tasks as:

• Assisting with a range of product development activities
• Facilitating and supporting ongoing strategic planning
• Managing the development and execution of annual plans including goals, strategies, and tactics
• Helping work streams and product teams plan, execute, track and report on tactics, including clinical trial development and implementation, advisory boards, publications, symposia, and conference presentations, among many others.
• Administrating and tracking departmental budgets
• Assisting with program and portfolio strategies aligned with product lifecycles
• Implementing tools that connect Medical Affairs with commercial programs while maintaining regulatory discipline
• Coordinating and maintaining relationships with and between Procurement, Finance, Contracting, and external vendors

Organizing for increased effectiveness

Even with their daily focus on implementing departmental tactics, strategies, projects and tasks, project managers recognize the need to carefully organize their own work situations in order to achieve maximum effectiveness. For one example, many project managers serve as the communications hub for the entire department. They keep various work streams continuously informed about the status of individual projects, in detail, while also alerting teams about how their individual projects may impact—and be impacted by—the activities of other areas within the department and other departments within the company.

This kind of multi-level communication responsibility is often a stand-alone function in other organizations. However, in the Medical Affairs project management portfolio, it can be one task among many. Project managers therefore have to prioritize their own time even as they address various departmental and company assignments. This self-organizational imperative must be strategically layered in among the general activities listed above, and also seamlessly interwoven with the execution of many specific tasks, which can include:

• Providing detailed status reports of each major initiative
• Developing and managing the contracting process with external vendor partners, including working with Legal and Contracts teams
• Reviewing vendor proposals and supporting contract negotiations
• Assisting in the planning and development of content for medical congresses
• Working with medical directors to find ways to leverage assets for multiple purposes that meet the needs of the medical community while maximize budget efficiencies while
• Interacting with opinion leaders and other healthcare professionals to: arrange speaking engagements and preceptorships, connect them with internal teams, facilitate introductions to company leadership, and process consulting agreements
• Retaining and maintaining institutional knowledge in the face of departmental turnover

In addition, many project managers are asked to find workarounds for departmental budget challenges, which can mean working across the department to minimizing expenses and maximize resources.

Functioning effectively amidst these varying forces and pressures requires not only a talent for organizing but a deep understanding of subtle aspects of each of the department’s functions and activities.

Anticipating departmental needs

If there is a single characteristic that is likely to make Medical Affairs teams value their project manager, it may be the ability to think ahead. There are always numerous ongoing and often competing demands, and new priorities seem to continually emerge. Since project managers often are asked to help the department unravel problems when they arise, they need to be able to look as far down the path as possible. That way, the manager will have the flexibility to take things in stride.

In short, it helps to stay at least one step ahead of the team, even as the manager remains fully aware of both the big picture and the small details.

To do this, they must get to know each Medical Affairs stakeholder. Project managers must also understand the drug development process, regulatory and compliance requirements, and legal implications. Ideally, they would also become familiar with the product, its clinical data, launch schedule, likely marketing trajectory, and projected lifecycle. When this information is readily available and thoroughly understood, a talented project manager will have an excellent chance to provide value on a daily basis.

You can maximize your project management function

Considering the challenges faced by project management in Medical Affairs, it makes sense to connect with people who know it inside and out. At CMK Select, we have the experience and training you need. In fact we have developed innovative processes designed to keep every aspect of your project management function humming. We are happy to share our expertise, or you can engage our highly-trained, expert staff, but, either way, you and your Medical Affairs department will benefit. Contacting CMK Select will boost your success, now and in the future.