Senior Clinical Data Manager/Principal Clinical Data Manager

Posted 13 days agoViewed

💎 Seniority level: Senior, 8+ years for a Sr. Clinical Data Manager and 10+ years for a Principal Clinical Data Manager

📍 Location: United States

💸 Salary: 113000.0 - 180000.0 USD per year

🏢 Company: Precision Medicine Group👥 1001-5000💰 $35,160,000 almost 4 years agoPharmaceutical Biotechnology Medical Precision Medicine Health Care

🗣️ Languages: English

⏳ Experience: 8+ years for a Sr. Clinical Data Manager and 10+ years for a Principal Clinical Data Manager

🪄 Skills: LeadershipProject ManagementSQLData AnalysisData MiningSAS EGProject CoordinationCommunication SkillsMicrosoft OfficeAgile methodologiesWritten communicationData entryData visualizationData modelingData analyticsData management

Requirements:

8+ years’ experience for a Sr. Clinical Data Manager and 10+ years for a Principal Clinical Data Manager
Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
Able to handle a variety of clinical research tasks
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

Responsibilities:

Manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects.
Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
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
Coordinate SAE/AE reconciliation
Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
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 related to data management and database management activities

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