Clinical Trials Manager

Foster City, CA


Contract Duration: 24-36 months


Rate: Negotiable


Salary: NA $1.00


Responsibilities:

• Excellent employment opportunity for a Clinical Trials Manager in the Foster City, CA area.
• Must meet all requirements for Sr. Clinical Trials Management Associate position and have demonstrated proficiency in all relevant areas
• Serves as the key operational contact with external investigators and internal stakeholders, for successful implementation of company, Collaborative (CO), Investigator Sponsored Research (ISR) Studies, expanded access programs, and compassionate use programs
• Has ability to critically evaluate scientific proposal or protocol, and budget for clinical operation feasibility and fair market value assessment
• Establishes strong partnerships with external investigators and collaborators to ensure ongoing activities (e.g. sponsor updates, drug shipments, publications, milestone payments, etc.) for CO and ISR studies are executed in a timely manner and with high quality
• Establishes strong cross-functional relationships and exhibits strong leadership skills with counterparts in other functional teams (e.g., CSM, CCF, DSPH, and Medical Affairs) to ensure efficient execution of the study management processes.
• Proactively identifies potential operational challenges and in collaboration with senior team members provides resolution plans to ensure study remains on track
• Implements and maintains working processes to promote high quality, efficient, and compliant systems and tools for CO and ISR study management
• Maintains a good understanding of industry standards and regulations for CO and ISR studies and keep abreast of any new changes and developments impacting Late Phase clinical operations.
• Organizes and leads clinical operational meetings
• Maintains internal Clinical Operations databases and document repositories
• For company studies, drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, and clinical study reports
• Must be able to understand, interpret and explain protocol requirements to others
• Maintains study timelines
• Coordinates review of data listings and preparation of interim/final clinical study reports
• Assists in determining the activities to support a project's priorities within functional area
• For company studies, contributes to development of RFPs and participates in selection of CROs/vendors
• For company studies, may be asked to train CROs, vendors, investigators and study coordinators on study requirements
• Contributes 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
• Participates 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

• 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
• Travel may be required
• Collaborates with local medical affairs colleagues on country specific studies and initiatives
• Provides knowledge and expertise on country specific regulations, site experience, and suitability for development studies
• 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