Senior Clinical Data Manager - CRO Experienced

4 days ago

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KCR

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Clinical Monitoring • Functional Service Provider • Site Set up and Contracting • Late Phase • Medical & Regulatory Affairs

501 - 1000 employees

Founded 1997

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Description

• Play a critical role in advancing drug and vaccine development programs. • Lead, plan, and execute data management tasks for assigned projects, ensuring data integrity, validity, and reliability. • Work in alignment with KCR standard operating procedures, industry best practices, and regulatory requirements while producing high-quality documentation.

Requirements

• Bachelor's degree in life sciences/pharmacy/biotechnology, nursing from an accredited US College/University. • At least 5 years of professional data management experience, preferably in pharmaceutical, biotechnology, or CRO industry with recent CRO experience given top priority. • Experience with Oncology study data, other Therapeutic areas beneficial. • Strong knowledge of monitoring guidelines, SOPs, GCP/ICH and applicable Guidelines. • Deep knowledge of late-stage clinical data management process; study start-up/execution/database lock. • Expert computer systems literacy, and adaptable to new technologies • Experienced user with multiple data collection systems including electronic data capture (EDC) technologies such as ePRO or eCOA, IRT, and at least one EDC tool such as Veeva CDMS, Medidata Rave, InForm, Oracle Clinical, Clincase, etc. • Excellent professional command of English language, written and spoken. • Ability to execute tasks in an accurate and timely manner with an emphasis on quality, organization, coordination, and project management.

Benefits

• 33 PTO days (inclusive of recognized holidays) + 1 additional for your birthday • A valuable healthcare and wellbeing benefits package (private health plans, life insurance, travel insurance, disability insurance, private retirement fund) • Loyalty and Referral Programs • Onboarding process and induction training to develop deep sector knowledge and complex skills. • Latest technology and the most advanced equipment and working tools. • Mentoring and training programs related to clinical trials, therapeutic areas, hard and soft skills.