Cro-Manager Of Data Management

Title: Manager of Data Management

Location: Remote

The Manager of Data Management contributes to and leads initiatives for the structure and development of the Data Management department. Responsible for both management and technical aspects of the Data Management elements of clinical trials. Manages the direction, planning, execution, and interpretation of all the Data Management activities related to clinical trials/research (Phase I-IV), including participating in defining corporate practices required for handling the data. Establishes and approves guidance procedures for Data Management related trial work and oversees implementation to ensure compliance with corporate standards for all clinical protocols.

Responsibilities:

• Responsible for working closely with internal and external functions, such as Programming, Biostatistics, Regulatory Affairs, and Project Management.
• Build and maintain data standards for clinical trials.
• Assist with study start up including protocol review, case form design, database design, data specifications, data transfer specifications, and review Data Management and handling plans.
• Develop and implement the data correction process, discrepancy resolution, data control activities, and data validation.
• Support clinical trial studies from preparation through closeout, including regulatory submissions by standardizing Data Management.
• Ensure documentation and management of clinical study data is in accordance with regulations.
• Proactively coordinate and perform start-up, processing and finalization activities as detailed in our SOPs.
• Proactively manage timelines and projections.
• Proactively manage project quality though supervision and Quality Control of team members’ work.
• Participate in reviewing and responding to QA audit reports.
• Proactively participates in appropriate sponsor/project team meetings.
• Lead and/or participate in User Acceptance Testing for projects as needed.
• Active involvement in departmental and organizational meetings and initiatives.
• Assist with development and documentation of department procedures.
• Participate in the review of the cross functional department procedures.
• Proactively coordinate and perform start-up, processing and finalization activities as detailed in our SOPs.
• Lead study setup including design, database structure, document creation including approvals.
• Communicate with cross functional groups throughout the project lifecycle. Monitors project scope.
• Maintain key vendor relationships such as EDC System Vendor, Statistical Group etc.
• Provide support to the business in the development of business development and promotional materials and the training of junior data managers.
• Participate in corporate development of SOPs, standardization efforts, methods, techniques and evaluation criteria for projects, programs and people. Has responsibility for internal performance management of junior staff, including training, coaching and performance reviews. Acts as a mentor to junior staff.

Supervisor Responsibilities:

Position supervises the work of assigned team members and has responsibility of workflow supervision of staff. Position requires extensive experience and judgment to accomplish study defined goals.

Education and /or Experience:

• BS/BA in health-related field or with life science, computing or nursing qualifications or 3 to 4 years equivalent experience.
• Minimum of 5 years of experience and or demonstrated aptitude for Data Management work. Minimum of 5 years of medication, clinical, or research related study or instruction or proven in role success equivalent to required years of experience.

Skills and/or Abilities:

• Excellent organizational skills.
• Strong written and verbal communication skills.
• Exceptional attention to detail.
• Technology proficiency including Data Management Systems.
• Study documentation production and maintenance, data processing, data review.
• Knowledge of clinical research including regulatory requirement GCP/ICH Data Quality.
• Strong interpersonal skills. Strong computer skills, including Microsoft Office.