- Oversees all project activities and coordinates cross-functional CRO and Sponsor delivery teams.
- Primary Point of Contact for the project (client and team)
- Prepare / Monitor / Update / Distribute overall (integrated) Project Timeline
- Manage / Monitor Distribute Project Budget
- Request / Establish file sharing structure
- Organizing and conducting the internal & external Kickoff meetings
- Scheduling (or delegating) of internal and external extended team calls
- Ensuring the Project team understands the SOW and their assignments
- Accountable for overall project delivery
- Deliverable quality
- Adherence to project budget
- Adherence to project timeline
- Communicate project delays to Business office/SDD leadership as soon as possible to inform project resourcing
- Responsible for Risk & Issue Log (as needed)
- Provide updates to the Status Report Monthly
- Establishes and implements Change Control processes to control project scope and schedules
- Initiating and coordinating change orders with the business office
- Completing project closeout activities
- Confirming acceptance of final deliverable
- Working with the business office to ensure final invoice is sent
- Sending client satisfaction survey
- Archival of all project deliverables and relevant documentation
- A minimum of a Master’s degree in life sciences or related field; advanced degree (MS, MD, PhD., Pharm. D.) desirable.
- Minimum of 10 years industry experience including a minimum of 3 years in a program management role (or equivalent experience).
- Direct experience with leading drug development teams in a matrix environment.
- Experience in a drug development functional role within the biopharmaceutical / device or CRO industry (e.g., Clinical Operations, Pre-clinical Development; Clinical Development, CMC, PK/PD, Regulatory Affairs, Program Management).
- Global-working/international experience in culturally diverse environments.
- Experience managing cross-functional teams / programs.
- In-depth regulatory, clinical, scientific, technical and/or therapeutic expertise.
- Strong knowledge of drug development.
- Strong project leadership capabilities.
- Knowledge of program management procedures and systems and skill in applying them creatively in a resource constrained environment.
- Excellent communication and interpersonal skills, including good command of English language.
- Proven ability to work through others to deliver results to the appropriate performance metrics.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Ability to balance operational and strategic priorities.
- Proficiency with software applications including Microsoft PowerPoint, Excel, Word, Project, Outlook, Teams, and Visio.
Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.