Sr. Clinical Trial Manager

Crinetics Pharmaceuticals • Headquarters, KY

6d

About The Position

Position Summary: The Senior Clinical Trial Manager is responsible for managing the execution of clinical studies and data collection. The incumbent oversees the review, monitoring, and adherence to clinical protocols, taking ownership of key projects and working independently. The Senior Clinical Trial Manager will interact internally and externally with members of the cross-functional study team and may supervise more junior CTMs and Associate CTMs as required. Essential Job Functions and Responsibilities: These may include but are not limited to: Provide oversight of clinical research studies across all functional areas of the drug development process. Provide operational and strategic input into study planning and study specific documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc. Coordinate and lead study team meetings and provide key stakeholders with updates on study progress including timelines, budget, and key milestones for the study. Develop the subject recruitment/retention strategy and related initiatives. Oversee TMF set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate site insurance, and/or supervision of team members performing these activities. Develop training materials for the study team, investigational sites, and vendors. Manage information proactively by sharing with key stakeholders using standardized reports and other mechanisms. Assure clinical studies are compliant with ICH/GCP and other regulations as appropriate. Oversee preparation of RFPs and prepare bid templates to facilitate selection of the CROs/vendors, and/or collaboration/supervision with team members performing these activities. Collaborate with counsel to negotiate and draft research contracts and agreements with CROs/vendors and clinical study sites, as needed. Acts as liaison with Regulatory Affairs to assure adherence to GCPs; maintenance of SOPs; and assure site and CRO/vendor audits are completed. Perform study risk management and implement mitigations. Identify potential study issues and recommend and implement solutions or corrective actions as needed. Create realistic plans that clearly define goals, milestones, responsibilities and results. Maintain focus on strategic objectives while accomplishing operational goals. Delegate assignments to direct reports. Manage and coach direct reports and provide career development opportunities in support of their individual development plans. Make timely, data-driven decisions. Other duties as assigned.

Requirements

• Bachelor’s degree required, preferably in a scientific discipline. An equivalent combination of relevant education and applicable job experience may be considered.
• Minimum of 8 years of prior clinical operations experience managing clinical trials, preferably with CRO/small biotech experience; at least 5 years in a supervisory role.
• Must be able to travel up to 10% of the time, may be higher in accordance with project requirements.
• Computer skills should include proficiency with Microsoft Office suite of software, electronic TMF systems, IRT and EDC systems.
• Excellent understanding of the drug development process.
• Able to make appropriate decisions to move the project(s) forward.
• Effective verbal and written communication skills.
• Data flow from sites to data processing, review, and resolution.
• Analysis and report generation.
• FDA regulatory requirements (i.e. GCPs, CFRs, etc.).
• The ability to handle multiple tasks to meet deadlines in a dynamic environment is essential.
• Study initiation procedures.
• Ability to exercise judgment and determine appropriate action.

Nice To Haves

• Experience managing early phase studies is preferred.
• Experience in rare disease and/or oncology is preferred.

Responsibilities

• Provide oversight of clinical research studies across all functional areas of the drug development process.
• Provide operational and strategic input into study planning and study specific documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
• Coordinate and lead study team meetings and provide key stakeholders with updates on study progress including timelines, budget, and key milestones for the study.
• Develop the subject recruitment/retention strategy and related initiatives.
• Oversee TMF set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate site insurance, and/or supervision of team members performing these activities.
• Develop training materials for the study team, investigational sites, and vendors.
• Manage information proactively by sharing with key stakeholders using standardized reports and other mechanisms.
• Assure clinical studies are compliant with ICH/GCP and other regulations as appropriate.
• Oversee preparation of RFPs and prepare bid templates to facilitate selection of the CROs/vendors, and/or collaboration/supervision with team members performing these activities.
• Collaborate with counsel to negotiate and draft research contracts and agreements with CROs/vendors and clinical study sites, as needed.
• Acts as liaison with Regulatory Affairs to assure adherence to GCPs; maintenance of SOPs; and assure site and CRO/vendor audits are completed.
• Perform study risk management and implement mitigations.
• Identify potential study issues and recommend and implement solutions or corrective actions as needed.
• Create realistic plans that clearly define goals, milestones, responsibilities and results.
• Maintain focus on strategic objectives while accomplishing operational goals.
• Delegate assignments to direct reports.
• Manage and coach direct reports and provide career development opportunities in support of their individual development plans.
• Make timely, data-driven decisions.
• Other duties as assigned.

Benefits

• In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.
• We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level