Clinical Data Manager II/Senior Clinical Data Manager

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects • Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s) • Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing • May perform quality control of data entry • Provide input, assesses and manage timelines • Conduct database build UAT and maintain quality controlled database build documentation • Responsible for creating, revising, appropriate versioning and maintaining data management documentation • Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed • Review and query clinical trial data according to the Data Management Plan • Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM • Run patient and study level status and metric reporting • Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency • Coordinate SAE/AE reconciliation • Liaises with third-party vendors • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders • Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation

🎯 Requirements

• Bachelors and/or a combination of related experience • 8+ years’ experience as a Sr. Clinical Data Manager or 5+ Years as a Clinical Data Manager II working for a Clinical Research Organisation, Pharmaceutical or Biotech company • Set up and Database migrations experience • Oncology experience preferred • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook • Excellent organizational and communication skills • Professional use of the English language; both written and oral • Experience in utilizing various clinical database management systems • Broad knowledge of drug, device and/or biologic development and effective data management practices • Strong representational skills, ability to communicate effectively orally and in writing • Strong leadership and interpersonal skills • Ability to undertake occasional travel

🏖️ Benefits

• Professional development opportunities • Flexible working hours