Manager, Clinical Operations (or Senior Manager)
Senior Director, Clinical Operations
Tavanta Therapeutics is a clinical stage specialty pharmaceutical company developing a diverse pipeline of drugs that bring clinically meaningful benefits to patients with serious or debilitating diseases. As we continue to grow and expand, there exists an immediate opportunity for a Manager, Clinical Operations (or Senior Manager) to join our Team. Reporting to the Senior Director of Clinical Operations, the incumbent will be responsible for the operational components of US‐based and global clinical trials across multiple phases of development ‐‐ ensuring on time, on budget, and high‐quality execution and conduct.
Essential Duties and Responsibilities
- In collaboration with the Senior Director of Clinical Operations, select and manage CROs and other consultants/vendors, including contract/budget negotiation, adherence to domestic and international regulations and standards (GCP and ICH), and overseeing CRO activities beginning from CRO award through trial close‐out
- Establishes and maintains collaborative, long‐term relationships with CRO personnel, outside consultants, investigators and institutions engaged in clinical trials
- Prepare or critically review project/study‐related documents (i.e., investigator brochures, protocols, informed consent, site instructions, study manuals, eCRFs, data review plans, etc)
- Works with CRO database providers to develop reports, summaries, listings which are needed for tracking study status or for various meetings
- Identifies challenges to study timelines/deliverables and offers creative action plans to the team, and contributes to regular team meetings to discuss trial operation details (including agenda/minutes and tracking action items related to study status, recruitment plans, risk‐mitigation plans, etc)
- Ensures completeness of internal documentation as well as trial master files, in accordance with applicable regulations, industry accepted standards, and SOPs governing clinical studies
- Responsible for the accurate budgeting and forecasting for clinical programs, and reviews and tracks site/vendor milestones and invoices in collaboration with Project Management
- May perform visits to sites and/or CROs to assess progress of studies and/or protocol compliance
Knowledge, Skills and Behaviors
Education and Experience
The candidate will have a Bachelor of Science in a scientific discipline; Master of Science preferred. In addition, the candidate should have a minimum of 5 years direct experience with clinical trial management working in a small biotechnology, a CRO and/or pharmaceutical company.
- Thorough understanding and working knowledge of both FDA and ICH Quality requirements for pharmaceutical drug development including a strong, demonstrated understanding of GCPs
- Must have extensive, demonstrated experience collaborating with and managing CROs
- Must have early stage clinical research experience (Phase 1 and/or Phase 2). Global Phase 3 experience is a plus.
- Effective verbal and written communication skills; medical writing experience is preferred
Skills and Behaviors
The candidate must be able to work both independently as well as part of a team.
Required skills and behaviors include:
- Team‐oriented and goal‐driven while being self‐aware of strengths and weaknesses
- Ability to think creatively, work within a multidisciplinary team environment, and collaborate effectively
- Able to adapt to a changing environment, be flexible, and be willing to try and learn new things/approaches
- Able to work in a fast‐paced environment: well‐organized, self‐directed, and able to manage multiple tasks
- Persistent and optimistic about overcoming obstacles and uncertainty
- Ability to pro‐actively identify and solve problems that threaten timelines and successful completion of clinical trials
This position will be in the Greater Philadelphia, PA region with the possibility of up to 25% domestic and global travel.