Clinical Project Manager
Position Description
The Clinical Project Manager is responsible for the overall management and coordination of operational activities involved in the planning, conduct and completion of clinical trials including the management of deliverables, adherence to budget, and ongoing risk mitigation. The Clinical PM leads cross functional project teams (clinical monitoring, data management, biostatistics, medical writing, medical affairs, regulatory affairs, and clinical QA) to ensure the project is completed on time, within budget, and with high quality. The Clinical PM must possess the ability to work closely with all disciplines within a small company, displaying innovative thinking, a strong sense of responsibility and accountability, and integrity.
Responsibilities include but are not limited to:
- General:
- Drive the planning, formation and execution of timelines, while identifying and tracking the team's critical path
- Facilitate the project team kick-off meeting by identifying key stakeholders and resources
- Execute and control project activities, including scope, schedule, budget and risk associated with each assigned project. Report performance to senior management
- Establish communication plans for information distribution to team members
- Manage project/program meetings
- Conduct project/program reviews at significant milestones or gates to evaluate successes as compared to baseline estimates
- Integrate understanding of constraints across and within projects and recommend alternatives
- Identify and track key study metrics in order to identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed)
- Clinical:
- Assist the scientific staff in developing and reviewing protocols, investigator brochures, informed consent forms, clinical study reports and other scientific documents
- Assist with IND/CTA submission preparation
- Oversee the development of plans and execution of those plans related to site monitoring, safety management, data management and biostatistics
- Identify, evaluate, and select external vendors (central lab, CROs, consultants/contractors).
- Develop contracts for and perform ongoing management of vendors to ensure deliverables and performance adhere to contract
- Oversee the identification, selection and proper initiation of sites
- Oversee development of CRFs, clinical and safety databases, and shell Tables, Figures and Listings
- Plan, coordinate and conduct investigator meetings
- Plan, coordinate and conduct Data Safety Monitoring Board (DSMB) meetings
- With Medical Affairs, assess trends in data including adverse events, protocol violations, etc.
- Oversee timely database freeze and database lock. Participate in data review meeting.
- Maintain the Trial Master File for each project and oversee the archival process
- Ensure adherence to SOPs, Good Clinical Practice and FDA/ICH regulations
- Strategic:
- Build strong peer relationships with leadership and business partners in an effort to most effectively progress new product development and strategic initiatives
- Guide the management of due diligence activities in support of new business or product opportunities
Qualifications:
- BS in scientific discipline or pharmacy, RN, or BSN degree or equivalent experience
- 3-5 years of clinical trial experience including some experience in all functional areas involved in clinical trials or direct project management experience
- Oncology background or experience is preferred
- Ability to travel approximately 20-40% travel based on study demands
- Excellent working knowledge of GCP/ICH Guidelines
- Effective written communication skills and computer skills are required
Salary:
Competitive compensation package commensurate with experience
Please submit your resume to: HR@Jennerex.com
Your resume is very important to us. In order to process your resume in the most efficient manner possible, Jennerex strongly encourages you to apply online. It is not necessary to send a back-up hard copy resume. Thank you for your cooperation with our process and, most importantly, your interest in Jennerex.
