Clinical Trial Manager

6 days ago

🏄 California – Remote

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

💵 $120k - $150k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🧪 Clinical Research

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Crinetics Pharmaceuticals

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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.

Drug Discovery • Endocrinology • RareDisease • Biotech

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• The Clinical Trial Manager is responsible for managing the execution of clinical studies and data collection. • Provide oversight of clinical research studies across all functional areas of the drug development process. • Provide operational and strategic input into study documents such as synopsis, protocol, ICF, CRFs, etc. • Develop the subject recruitment/retention strategy and related initiatives. • Oversight of TMF set-up and ongoing quality review. • Development of training materials for study team and investigational sites. • Proactive management of information sharing with key stakeholders. • Assure clinical studies are compliant with ICH/GCP and other regulations. • Oversee preparation of RFPs and collaborative contracts. • Perform study risk management and implement mitigations. • Create realistic plans that define goals, milestones, responsibilities, • Manage daily activities, assign tasks, goals, and development of direct reports. • Other duties as assigned.

🎯 Requirements

• Bachelor’s degree required, preferably in scientific discipline • Minimum of 7 years of prior clinical operations experience • 2 years of experience in a supervisory role • Experience in early phase studies preferred • Computer skills including Microsoft Office suite, electronic TMF systems, CTMS, IRT, and EDC systems • Excellent understanding of drug development process • Effective verbal and written communication skills • Ability to handle multiple tasks to meet deadlines in a dynamic environment

🏖️ Benefits

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