Senior Manager, Clinical Data Management

Job not on LinkedIn

November 18

🏄 California – Remote

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

💵 $138k - $172k / year

⏰ Full Time

🟠 Senior

👔 Manager

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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

• Manages the assigned study/studies and makes expert recommendations and/or decisions that assure timelines, deliverables and data quality. • Collaborates cross-functionally to resolve clinical data issues and ensure effective communication throughout the drug development process. • Resolves and/or escalates issues encountered at the study level and ensures the performance of the data management function. • Provides effective CRO/vendor oversight to ensure requirements are met and the project plans are executed to meet the development needs. • Leverages data management and related expertise to promote best practices across the drug development lifecycle and enhances collaboration with relevant stakeholders. • Contributes to team building and best practice to achieve the defined data quality with cost efficiency. • Participates in regulatory audit and/or company initiatives.

🎯 Requirements

• MS/BS in life sciences or related field • 7 + years of direct data management experience and at least 3 years of CRO oversight experiences • In depth knowledge of clinical data management in the Biotech, Pharmaceutical or CRO industry • Strong project management skills and experiences working with CROs/vendors • Demonstrated organizational and interpersonal skills • Detail oriented with excellent communication skills and extensive experiences working in cross-functional setting • Highly knowledgeable and experienced in CDISC standards, SDTM requirements, and CFR-Part 11 Compliance • Knowledge of GCP, ICH and other regional regulations and compliance • Experiences with clinical data lifecycle from database set-up and maintenance to database lock and archiving • Working knowledge of current technologies in clinical trial data collection systems.

🏖️ 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