Crinetics Pharmaceuticals
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.
Senior Manager, Clinical Data Management – External Data Management
🕒 May 30
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Crinetics Pharmaceuticals
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
• Execute and own external data management activities for assigned clinical studies • Develop and maintain Data Transfer Agreements (DTAs) and external data specifications • Coordinate and perform test data transfers with hands-on QC • Import, validate, and reconcile external datasets • Collaborate with Clinical Operations, Biostatistics, and Regulatory teams • Support regulatory inspections as the external data management subject matter expert
🎯 Requirements
• MS/BS degree in life sciences, health informatics, computer science, or a related field • 8+ years of progressive clinical data management experience (or 12 years with a Bachelor's degree) • Proven expertise in managing complex external data • Strong working knowledge of EDC systems and clinical data regulations • Proficiency with SAS (or similar) for data validation and reconciliation • Solid understanding of ICH-GCP, 21 CFR Part 11 • Ability to work independently with minimal oversight while managing multiple priorities
🏖️ Benefits
• Health insurance plans (medical, dental, vision, and basic life insurance) • 401k match • Discretionary annual target bonus • Stock options • 20 days of PTO • 10 paid holidays • Winter company shutdown
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