Clinical Trial Manager

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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

• 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 • Develop the subject recruitment/retention strategy and related initiatives • Oversight of TMF set-up, ongoing quality review, and final reconciliation of study documents • Develop training materials for study team, investigational sites, and vendors • Proactively manage information sharing with key stakeholders using standardized reports • Assure clinical studies are compliant with ICH/GCP and other regulations • Collaborate with counsel to negotiate and draft research contracts and agreements

🎯 Requirements

• Bachelor’s degree required, preferably in scientific discipline • Minimum of 7 years of prior clinical operations experience preferably with CRO/small biotech experience and 2 years of experience in a supervisory role • Experience in early phase studies is preferred • Proficiency with Microsoft Office suite of software, electronic TMF systems, document repository, CTMS, IRT, and EDC systems • Excellent understanding of drug development process • Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential

🏖️ 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