Senior Clinical Data Manager - REMOTE

Proclinical is seeking a remote Senior Clinical Data Manager for a cutting-edge biotech company.

The Senior Clinical Data Manager will be responsible for performing end to end Data Management activities. He/she will participate as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. The Senior Clinical Data Manager must have a broad, fundamental knowledge of the data management process and should be able to perform most required tasks with minimal guidance.

Must be eligible to work in the US.

Job Responsibilities:

• Lead a large clinical study or a series of related studies with minimal guidance
• Represent Data Management at study management team meetings
• Provide mentoring and training to lower level Data Management staff assigned to his/her studies Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts
• Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
• Be able to perform a thoroughly detailed review of eCRF data requirements and create one if need be
• Interact with CRAs, programmers, study operations lead and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
• Lead the development of data edit check specifications and data listings
• Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company processes
• Able to resolve EDC system issues with team members
• Develop or lead the development of the Data Management Plan for a clinical study.
• Able to review and provide feedback to the clinical team on other study documents Statistical analysis plans and vendor specifications
• May provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed
• Perform reconciliation of data from external data sources against the clinical database
• Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
• Lead database upgrades/migrations including performing User Acceptance Testing
• Perform database lock and freeze activities per company SOPs
• Must adhere to core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Skills and Requirements:

• At a minimum, Bachelor's Degree required in the scientific/healthcare field.
• At least 5 years' experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience
• Must have good project management skills and a proven ability to multitask
• Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. Possesses strong English language written and verbal communication skills.
• Experience in working with oncology studies
• Able to travel to off-site meetings or training seminars as needed.
• Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications.
• Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable.

If you are having difficulty in applying or if you have any questions, please contact Merna Hermiz at (+1) 323-306-2409 or m.hermiz@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-MH2