Senior Clinical Trials Manager
Proclinical is currently recruiting for a Senior Clinical Trials Manager for a global pharmaceutical company located in Foster City, CA. Successful candidate must establish strong partnerships with external investigators and collaborators to ensure ongoing activities.
- Serve as the key operational contact with external investigators and internal stakeholders
- Establish strong cross-functional relationships and exhibits strong leadership skills with counterparts in other functional teams to ensure efficient execution of the study management processes.
- Identify potential operational challenges and in collaboration with senior team members provide resolution plans to ensure study remains on track
- Maintain a good understanding of industry standards and regulations and keep abreast of any new changes and developments impacting Late Phase clinical operations.
- Organize and lead clinical operational meetings
- Maintain internal Clinical Operations databases and document repositories
- Draft and coordinate review of relevant documents including protocols, informed consents, case report forms, monitoring plans, and clinical study reports
- Maintain study timelines
- Coordinate review of data listings and preparation of interim/final clinical study reports
- Contribute to development of study budget
- May serve as a resource for others within the company for clinical trials management expertise
- Able to examine functional issues from an organizational perspective
- Participate in the recruiting and hiring process for CPA/CTMA/Sr. CTMA and support their professional development
- May contribute to development of abstracts, presentations and manuscripts
- Under supervision, may design scientific communications within the company
- Collaborate with local medical affairs colleagues on country specific studies and initiatives
- Provide knowledge and expertise on country specific regulations, site experience, and suitability for development studies
Skills and Requirements:
- BA/BS or MA/MS required with at least 4-7+ Clinical Managerial experience
- Phase 4 experience is preferred
- Has ability to critically evaluate scientific proposal or protocol, and budget for clinical operation feasibility and fair market value assessment
- Must be able to understand, interpret and explain protocol requirements to others
- Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
- Must have a general, functional expertise to support SOP development and implementation
- Must be able to travel
- Excellent teamwork, communication, decision-making and organizational skills are required
- Thorough knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies
- Working knowledge and experience with Word, PowerPoint and Excel
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nikki Ranieri at (+1) 215-531-5288 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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