Associate Manager, Clinical Monitoring

Crinetics Pharmaceuticals•Headquarters, KY

1d•$115,000 - $144,000•Onsite

About The Position

The Associate 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. This role may conduct Clinical Monitoring visits for assigned Crinetics studies. The Associate Manager may support the development of processes, procedures, and tools/templates related to monitoring and site management activities.

Requirements

BS in biological sciences or related discipline with at least 5 years of experience working in the biotechnology/pharmaceutical industry.
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.
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 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.

Nice To Haves

Experience in endocrine disorders preferred.

Responsibilities

With direction from CTO or Clinical Monitoring management, 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 direction from CTO or Clinical Monitoring management, manage the monitoring oversight strategy, including risk-based approaches, to assess the quality and compliance of CRO or FSP partners on assigned studies.
Manage or conduct monitoring oversight visits (MOVs) with CRO CRAs to assess compliance to the protocol and Clinical Monitoring Plan and document results of the visit.
Review monitoring visit reports from CRO CRAs and escalate monitoring trends or findings to CTO and Clinical Monitoring management.
Conduct or participate in Clinical Monitoring visits for Crinetics studies.
Mentors and provides leadership and direction to the CRA team members on study related questions from start-up through closure.
Ensure adequate resourcing for CRAs on assigned Crinetics studies; work with CTO to plan for CRA re-assignment or acquisition of additional resources.
Escalates any study-related issues or impacts on deliverables, as appropriate, to the Clinical Monitoring management.
Support CRAs, study team, and Quality with responses to audits or inspections.
May provide feedback and assist with the development of departmental policies and procedures toward increased efficiency and quality of deliverables.
May contribute to the development of SOPs and other procedural documents.
May conduct monitoring assessment or FSP oversight visits as needed.
Support development and manage Clinical Monitoring budget requirements for assigned studies.
Other duties as assigned.