Clinical Project Manager / Senior Clinical Project Manager
About The Position
The role of Clinical Project Manager/Senior Clinical Project Manager will report to the Associate Director, Clinical Project Management, and work collaboratively across functions to manage clinical activities that will bring novel cancer therapeutics to patients in need. The Clinical Project Manager/Senior Clinical Project Manager will be assigned to one or more clinical trials and be responsible for the day-to-day operations of the trials. The ideal candidate is self-motivated, curious, detail oriented, works collaboratively and has highly relevant experience. Volastra is a fast-paced biotech company of passionate employees with opportunities for the ideal candidate to grow and develop with the organization. Individuals will have, from time to time, the opportunity to gain experience with projects outside their direct scope of work. Job is based in NYC with a flexible option for hybrid work.
Requirements
- Bachelor’s degree in a relevant field
- Minimum of 3 years of relevant industry experience, including at least 1 year in a Sponsor role at a biotech or pharma company
- Experience in management of in house and outsourced clinical trials
- Experience in early phase clinical trials
- Experience in oncology
- Strong working knowledge of ICH GCP guidelines and project management concepts
- Excellent communication, organizational, problem-solving and conflict resolution skills
- Experience working with CTMS, EDC and eTMF systems preferred
- Ability to travel domestically (<10%)
Responsibilities
- Plans, implements and monitors progress of assigned clinical trials from start up to closeout
- Collaborates with cross functional study team to execute clinical study deliverables .
- Tracks and manages deliverables from CROs and vendors
- Develops and manages tools to track clinical study progress
- Ensures compliance with SOPs, GCP and other applicable regulations
- Escalates study-related issues as appropriate
- Prepares and provides clinical study updates
- Participates in development/review of study documents and plans
- Reviews and approves study plans generated by CROs and vendors
- Reviews site informed consent drafts
- Proactively identifies risks and helps to implement mitigation strategies
- Implements enrollment and retention strategies
- Reviews and approves IP release packages
- Manages IP accountability and reconciliation processes
- Monitors clinical data collection, and reviews clinical data for completeness and accuracy
- Reviews monitoring reports to assess site performance
- Reviews and reconciles study related invoices
- Supports and participates in clinical team initiatives
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
