Clinical Trial Manager
Clinical Trial Manager
As the Clinical Trial Manager (CTM), you will direct and oversee all aspects of the clinical trial from site selection through study close-out with particular emphasis on study management and monitoring and how these two functional areas interact and are coordinated with data management, biostatistics & reporting and project management. The CTM shall have a direct pulse on the overall conduct of the trial and serve as the primary point of contact for the project team on planning and execution of the trial.
Specific responsibilities shall include the following:
• Partnering with other internal staff and contractors within Clinical Operations, coordinate drafting of the protocol, protocol amendments, informed consent form templates, manual of operations, communication and rollout of new study procedures to the project team and investigative sties, updates to www.clinicaltrials.gov, current investigator site list, maintenance of the TMF, monthly site newsletters and protocol deviation tracking.
• Ensure the success of the clinical trial by selection of appropriate sites, executing successful investigator’s meetings, implementing effective recruitment strategies and communicating with sites, either directly or indirectly via contract clinical research associates, through a communication escalation plan.
• Provide technical and study-specific input into essential documents and other study operational documents created internally or by external third-party vendors. Study documents shall include, but not be limited to, the following: communication plan, monitoring plan, study management plan, site recruitment plan, clinical supply plan, data management plan, data validation plan, and statistical analysis plan.
• Coordinate and lead efforts with the appropriate internal and external parties in finalizing content, organization and structure of study-related procedures manuals, such as the PET acquisition protocol, pharmacy manual and patient recruitment materials including all aspects of implementation.
• Train, both initial and ongoing training as needed, contract clinical research associates (CRAs) on all technical aspects of the protocol and all operational procedures in order for the CRAs to carry out their function and for the CRAs to perform the various types of visits (Pre-study Site Visits, Site Initiation Visit, Site Close-Out Visit) in an effective manner.
• Provide all necessary tools and materials (e.g., slide decks) for the CRAs to perform all the various types of visits.
• Set protocol-specific agenda items for the routine CRA call and participate in discussion of study updates and timelines, answer any questions, and seek feedback from the CRAs on protocol-specific issues and concerns.
• Help implement new administrative procedures with the contract CRAs, including the following: (a) expectations of contract CRAs taking a more active role in site management to include weekly site interactions on recruitment and screening efforts and collection of data that is rolled up into a master weekly spreadsheet and available no later than close of business on Friday to the project team; (b) proactively scheduling monitoring visits well in advance including visits to discuss recruitment efforts and action plans around recruitment; and (c) expectation and standard practice of providing final confirmation letter, draft trip report and draft follow-up letter on or before invoicing for billable hours for that particular monitoring visit.
• Partnering with staff and contractors/vendors within Clinical Operations, coordinate study-specific tools and templates including confirmation and follow-up letter templates, annotated trip reports, trip report and monitoring visit trackers, core lab trackers, electronic data capture authorization of user access and user privileges, source document worksheets, etc.
• Coordinate monitoring efforts around any and all data cuts (e.g., data cutoff for data monitoring safety committee, IND annual reports, interim analysis).
Preferred educational background and skills required:
• Bachelor’s Degree and/or equivalent with 6-10 years of clinical research experience in the biopharmaceutical industry.
• Working knowledge of FDA regulations, DIA Reference Model and ICH guidelines regarding GCPs.
Knowledge, Skills and Attributes:
• Proven ability to multi-task and prioritize.
• Well-organized, detail-oriented, possess a sense of urgency.
• Team-oriented with very good communication and interpersonal skills.
• Excellent computer skills in the following programs: MS Outlook, Project, Word, PowerPoint and Excel.
• Some travel may be required to sites or to study-related meetings.
• This is an office-based position in San Diego, California.
• Level of this position can be adjusted to Senior or Associate Director depending on background and depth & breadth of prior experience.