Job Description
Position Summary:
The Manager, Clinical Monitoring supports global and regional clinical trial operations (CTO) and Clinical Monitoring management in the conduct and oversight of clinical site management and monitoring activities performed by Crinetics or an outsourcing partner. The Manager will supervise Clinical Research Associates (CRA) and support the development of processes, procedures, and tools/templates related to monitoring and site management activities.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
- With support from CTO or Clinical Monitoring management, develop and implement strategy for in-house, regional monitoring activities on assigned studies applying a risk-based approach when indicated.
- Lead monitoring activities on assigned studies. This can include review of protocols, CRFs and completion guidelines, study manuals and other related documents.
- Author or review Clinical Monitoring Plan in collaboration with CTO and ensure CRA compliance to current plan.
- Manage the CRA monitoring visit schedule for each assigned study ensuring visit frequency and scheduled time on site aligns with risk-based indicators and site metrics.
- Review and finalize visit reports for regional CRAs managed by Crinetics according to study timelines. Follow up with CRAs regarding outstanding trip reports and follow-up letters.
- Track status of action items and queries.
- Maintain, and/or act on metrics related to CRA performance or site status.
- Support CRAs and CTO with the implementation of site corrective actions related to issues identified during monitoring activities.
- Track and report to study team and leaders on compliance, trends and metrics related to monitoring and site management.
- Support TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents as needed.
- With support from CTO or Clinical Monitoring management, develop and manage the monitoring oversight strategy, including risk-based approaches, to assess the quality and compliance of CRO or FSP partners on assigned studies.
- Manage conduct of monitoring oversight visits (MOVs) with CRO CRAs to assess compliance to the protocol and Clinical Monitoring Plan and document results of the visit. May perform MOVs as needed.
- Review monitoring visit reports from CRO CRAs and escalate monitoring trends or findings to CTO and Clinical Monitoring management.
- Mentor and provide leadership and direction to the CRA team members on study related questions from start-up through closure.
- Provide management and/or oversight of assigned Crinetics and FSP CRAs responsible for Clinical Monitoring activities.
- Conduct monitoring assessment or FSP oversight visits with assigned CRAs to ensure quality monitoring performance; use findings from visit to direct additional support, training, or performance management.
- Ensure adequate resourcing for assigned CRAs to Crinetics studies; work with CTO to plan for CRA re-assignment or acquisition of additional resources.
- Conduct annual performance assessment activities including appraisals, salary recommendations, and promotion justifications for Crinetics employees.
- Lead or participate in interviewing, hiring, onboarding, and orientation processes for Crinetics or FSP CRAs.
- Conduct or arrange training for Crinetics or FSP CRAs on SOPs, WIs, ICH-GCP, local regulations, and other role-specific training. Ensures all training gaps are identified and resolved for assigned team.
- Responsible for team administrative oversight such as expense reports, travel approvals, and time-off requests.
- Escalates any performance, resourcing, training, or study-related issues or impacts on deliverables, as appropriate, to the Senior Director, Clinical Project Management and Centralized Services.
- Support CRAs, study team, and Quality with responses to audits or inspections.
- Other duties as assigned.
Education and Experience:
Required:
- BS in biological sciences or related discipline with at least 7 years of experience working in the biotechnology/pharmaceutical industry. Experience in endocrine disorders preferred.
- A minimum of 2 years in a supervisory role.
- Demonstrates critical thinking, root cause analysis and problem solving to support CRAs with identifying site process failures; assist CRAs to develop corrective and preventative actions to bring sites into compliance.
- An understanding and demonstrated application of Good Clinical Practices, ICH Guidelines and regulatory requirements. Able to comply with safety standards and respect privacy and confidentiality.
- In-depth experience with cross functional drug development with prior regulatory inspection experience preferred.
- Excellent writing skills as they relate to the preparation of clinical trial documents.
- Excellent interpersonal skills with strong oral/written communication and presentation skills
- Excellent negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved.
- Demonstrated leadership and management skills.
- Good judge of risks and a keen ability to analyze options and manage outcomes.
- Well-versed with the latest trends in the clinical trial industry.
Preferred:
- Monitoring experience in startup, execution and close out activities related to clinical studies; experience using risk-based monitoring processes strongly preferred.
- Previous experience as a Lead CRA, Trial Manager, or equivalent strongly preferred.
Physical Demands and Work Environment:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Travel:
You may be required to travel for up to 30% of your time.
Equal Opportunity Employer:
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Salary Range
The salary range for this position is: $132,000 - $165,000.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.
Originally posted on Himalayas
