Exel
Clinical Trials Manager (Biotechnology, Oncology)
Alameda, CA
Sponsorship not specified$136k-$193kDetected 31 days ago
GCPExcelClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceResearchLeadershipCommunicationCollaborationProblem SolvingPublic SpeakingGxPRegulatory Affairs
About the role
- SUMMARY/JOB PURPOSE: The Clinical Trials Manager (CTM), Clinical Operations, coordinates the activities associated with the evaluation, initiation, and management of clinical trials.
- The base pay range for this position is $136,000 - $192,500 annually.
- The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
Responsibilities
- Manages clinical trials, including those conducted through Contract Research Organizations (CROs)
- May participate in developing and recommending operational strategies for clinical trials in collaboration with cross-functional teams
- Responsible for at least one geographical region and manages/oversees one to three external vendors within a specific scope (e.g., Lab)
- Maintains regular contact with relevant departments (e.g., Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.)
- Provides support for adherence/compliance to study plans (e.g., Verification of Performance (VOP)
- Ensures oversight of regulatory and essential documents
- Supports and oversees the development of study plans and documents (e.g., VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals)
- Coordinates the design, format, and content of study guides and subject instructions
- May support / be responsible for site and vendor invoice reviews
- Provides oversight to development and review of study documents (i.e. Protocol, ICF, CRFs, IRT specifications, Inv product labels, etc)
Requirements
- BA/BA/BSN in biological sciences or related field and a minimum of 7 years of related experience
- MS/MA/MSN in biological sciences or related field and a minimum of 5 years of related experience
- Typically requires a minimum of 7 years of related experience in life sciences, including 5 years in experience in clinical research
- Travel may be required up to 20% in support of clinical study activities
- It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
- May participate in strategic governance discussions as required (e.g., SAB, BOD, DT, TAT, DSC, DOC)
Skills
- Experience in either starting a study up, maintenance phase, or study close-out
- Experience with development of prospective site-selection criteria
- Protocol development experience
- Familiar with advanced concepts of clinical research
- Ability to deal with time demands, incomplete information or unexpected events
- Experience in interactions with outside vendors, e.g., CROs and contract labs
- Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations
- Demonstrated ability to write and present clearly using on scientific and clinical issues terminology
- Strong organizational and planning skills
- Strong interpersonal skills and communication skills (both written and oral)
- Ability to work effectively in a team/matrix environment
- Education/Experience:
Compensation
- The base pay range for this position is $136,000 - $192,500 annually.
- The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
Benefits
- The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
- Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.