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 For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $75M Private Equity Round on 2015-12

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 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, assess and manage timelines • May develop CRF specifications from the clinical study protocol • 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 • Liaise with third-party vendors such as external data and EDC vendors • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies • Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities • Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues

🎯 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

• Health insurance • 401(k) matching • Flexible work hours • Paid time off