Description
Syneos Health is seeking a skilled and motivated Sr. Project Manager to join their sponsor-dedicated team supporting high-impact inflammation trials.
In this role, you will work full-time on behalf of a leading biopharmaceutical sponsor while employed within a global CRO,offering the best of both worlds: sponsor collaboration and CRO resources.
Responsibilities:
- In partnership with Clinical Program Manager or Associate Director, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
- Communicates with functional peers regarding project status and issues and ensure project team goals are met
- Oversees operational aspects of assigned clinical trial(s) and oversees clinical trial conduct including study start-up, enrollment, maintenance and close-out
- Prepares and/or contributes to development of study-related documents (e.g., Clinical protocols, Informed consent forms, Pharmacy Manual, Monitoring Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study Report)
- Coordinates data review to support interim/final data analysis
- Participates in study strategy development
- Maintains study timelines
- Contributes to development of study budget
- Contributes to development of RFPs and participate in selection of CROs/vendors
- Provide guidance and training to CROs, vendors such as IWRS, Central lab, eCOA, recruitment vendors, investigators and study coordinators on study requirements
- Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management)
- Proactively identifies potential study issues/risks and recommends/implements solutions
- Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
- Participates in the recruiting and hiring process for CPA/CTMAs and supports their professional development
- Coaches members of a work team and ensures adherence to established guidelines
Requirements:
- Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
- Extensive Study Start-up Experience
- Global clinical trial experience
- Prior involvement in Inflammation studies
- Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management
- Highly developed leadership skills to successfully lead a clinical study team
- Ability to deal with time demands, incomplete information or unexpected events
- Must display strong analytical and problem solving skills
- Attention to detail
- Outstanding organizational skills with the ability to multi-task and prioritize
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
Benefits:
- Company car or car allowance
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time