Senior Project Manager, COA Program

ABOUT CRITICAL PATH INSTITUTE

Critical Path Institute (C-Path) is a nonprofit engaged in the creation of partnerships and innovative processes that improve human health by reducing the time, cost, and risk in developing and approving new therapies.

For over fifteen years, we have partnered with industry and academic experts to advance technologies across the spectrum of medical product development from research to regulatory approval.

As a leading nonprofit organization dedicated to fostering collaboration and promoting data sharing in the precompetitive space, C-Path has been at the forefront of numerous advances designed to get new treatments to patients quicker.

Our continuing success is made possible by a combination of public and private support from those who share our vision to accelerate a path to a healthier world.

POSITION OVERVIEW

The Senior Project Manager will support the Executive Director (ED) of the eCOA Consortium (eCOAC) in strategic development, planning, and execution of eCOAC projects, collaborative efforts and broader initiatives aligned to the eCOA Consortium's mission.

This position can be remote.

Project teams within eCOA Consortium-led or co-led efforts typically consist of small groups made up of C-Path scientific staff, external stakeholders (e.

g., member firm representatives, COA experts, regulatory stakeholders), and project management staff working together in a collaborative environment to accomplish individual project, and overall consortium / program goals.

Each project typically consists of a scientific lead, one or two scientific support staff (within or external to C-Path), an assigned project manager, and support from a project coordinator.

Scientific staff are responsible for oversight of the scientific content of eCOA work undertaken by each project team. Project managers are expected to facilitate the project by establishing project objectives, defining the meeting strategy, developing agendas, taking meeting minutes / notes, managing documentation developed as part of the project, tracking, and reporting on project progress.

They are supported by a project coordinator who is responsible for sending out meeting invitations and finalized agendas, scheduling ad-hoc meetings, and taking roll on project team calls as requested.

Project managers report to the COA Program's Associate Director, who oversees and coordinates project management and operations across the COA Program.

Success in this role will require outstanding verbal and written communication skills, time management skills, project management skills, attention to detail, problem-solving skills, and a collaborative mindset.

SUPERVISORY RESPONSIBILITIES

None

CORE / RESPONSIBILITIES

• Collaborate with eCOAC leadership to provide operational, and administrative oversight of eCOA Consortium led and co-led project activities.
• Manage day-to-day operational aspects of all eCOA Consortium-related activities.
• Develop and guide the execution of project plans, task lists, milestones, and timelines for supporting project deliverables and milestones.
• Lead development, publication and promotion of eCOA Consortium-related social media and website materials.
• Lead both Consortium-level and project-level teleconferences to ensure progress towards eCOA Consortium objectives.
• Provide input to strategic planning and actively contribute to leadership activities of the eCOA Consortium.
• Contribute to initiatives and efforts that support the strategic goals of the broader COA Program and C-Path.
• Prepare agendas, minutes, action items for all eCOA Consortium meetings as required.
• Support the expansion of eCOA Consortium membership.
• Collaboratively plan and support the execution of face-2-face meetings (one US, one EU) for the eCOA Consortium.
• Travel on occasion for out-of-town meetings (max 5%)

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Demonstrated ability to lead external teams and guide productive discussions to achieve team objectives.
• Strong project management skills including :
• Strong interpersonal, organizational, and meeting management skills.
• Excellent attention to detail and problem-solving skills.
• Excellent time management skills combined with strong collaboration and team-building awareness.
• Excellent writing and copy-editing skills
• Excellent oral and virtual communication skills
• Ability to organize and track progress of deliverables for multiple on-going projects.
• Demonstrated ability to effectively present data, development plans, and strategies to various audiences in both verbal and written form;

demonstrated ability to author internal and external communication (e.g., documents, presentations, and email messages) that are clear and concise.

• Demonstrated ability to work collaboratively, think strategically, and use an inclusive and consultative approach to problem-solving and decision-making.
• Ability to adapt to shifting priorities, demands, and timelines.
• Ability to work independently and in a team-oriented, collaborative environment.
• Intermediate to advanced knowledge of budgeting concepts, terminology, and forecasting.
• Ability to anticipate issues or challenges and proactively addresses them without being specifically directed.
• Ability to exercise sound business judgment when making decisions and adhere to external and internal policies and regulations.
• Successfully anticipates issues or challenges and proactively addresses them without being specifically directed.
• Understanding of the use of electronic patient-facing systems in clinical trials or healthcare more broadly preferred.
• Knowledge of regulatory guidance related to eCOA and DHT is desirable.
• Expert with Microsoft Office Suite : Word, Excel, PowerPoint, Outlook, and SharePoint.
• Expert with project management software (e.g., monday, MS Project).
• Proficient with Adobe Acrobat Pro for creating / assembling complex documents.
• Expert with standard office meeting / communication software including Zoom and
• Proficiency in social media and web-based resource development is desirable.

REQUIRED EDUCATION AND EXPERIENCE

A bachelor's degree in public health, business, or related scientific field (e.g., biochemistry, immunology, chemistry, pharmacology).

An advanced degree (e.g., MBA, MS, PhD) is

• PM P or equivalent certification required
• 7 - 10 years of formal project management

The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills.

Other duties m ay be added, or this description amended at any time.

Critical Path Institute is an equal opportunity employer. Visit our website at

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