Associate Manager, Clinical Monitoring

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Crinetics Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Crinetics Pharmaceuticals is a biotechnology company that develops innovative therapies for endocrine diseases. The company is focused on addressing unmet medical needs by creating treatments for conditions such as acromegaly, carcinoid syndrome, ACTH-dependent Cushing’s syndrome, congenital adrenal hyperplasia, and other endocrine disorders. Crinetics is committed to improving the quality of life for patients through cutting-edge science and robust clinical trials. Their pipeline includes promising candidates like paltusotine, which has been accepted by the U. S. Food and Drug Administration for the treatment of adult patients with acromegaly. The company collaborates with healthcare practitioners and stakeholders to ensure that their therapies address real-life problems effectively and build value for investors by entering market niches with significant needs.

📋 Description

• Support 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. • Conduct Clinical Monitoring visits for assigned Crinetics studies. • Lead monitoring activities on assigned studies, including review of protocols, CRFs, completion guidelines, and study manuals. • Author or review Clinical Monitoring Plan in collaboration with CTO and ensure CRA compliance to current plan. • Manage 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. • Maintain and act on metrics related to CRA performance or site status. • Support development and manage Clinical Monitoring budget requirements for assigned studies.

🎯 Requirements

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

🏖️ Benefits

• Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance • 20 days of PTO • 10 paid holidays • Winter company shutdown • Discretionary annual target bonus • Stock options • ESPP • 401k match