Clinical Trial Manager, Phase 3

Job not on LinkedIn

November 26

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $122k - $152k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🧪 Clinical Research

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Crinetics Pharmaceuticals

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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.

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Responsible for executing phase 3 clinical studies and data collection • Provide oversight of late-phase clinical research studies • Develop subject recruitment/retention strategy • Oversee TMF set-up and quality review • Create training materials for study teams and vendors • Ensure compliance with ICH/GCP regulations • Prepare RFPs and negotiate contracts with CROs/vendors • Perform study risk management and implement solutions • Maintain focus on strategic objectives while accomplishing operational goals

🎯 Requirements

• Bachelor’s degree required • 7 years of clinical operations experience, preferably with CRO/small biotech experience • 2 years in a supervisory role • Computer skills: Proficiency with Microsoft Office suite, electronic TMF systems, IXRS, and EDC systems • Excellent understanding of the drug development process • Effective verbal and written communication skills • Experience with FDA regulatory requirements (GCPs, CFRs, etc.) • Ability to handle multiple tasks and meet deadlines • Ability to exercise judgment and determine appropriate action

🏖️ Benefits

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