Manager Clinical Data Management
Reports To (Position): Executive Director, Clinical Development
Department Name: Data Management
Objective of Position
The Manager, Data Management (Mgr., DM) is responsible for all aspects of the DM process from project planning, the development of project documentation, system set-up, UAT through database lock. This person is a department-level contributor and may have oversight of junior DM staff.
Essential Duties/ Responsibilities
- Participates in the development, review, and implementation of departmental SOPs, templates, etc.
- Contributes to technical infrastructure of DM.
- Ensures adherence to timelines and quality of deliverables. May have responsibility for these functions with no direct reports.
- Provides feedback and task assignment to meet department and company goals.
- May have oversight of internal DM and/or consultant DM staff.
- Directs the activities of direct reports.
- Recruits, trains, and manages staff within area of responsibility.
- Provides feedback and task assignment to meet department and company objectives.
- Supports budget and resource planning across assigned projects.
- Participates in CRO/vendor selection process for outsourced activities.
- Participates in department or cross-functional initiatives.
- Represents DM in study team meetings.
- Manages DM timelines to coordinate and synchronize deliverables with the overall study timelines.
- Generates and/or reviews/approves study documents (e.g., study protocols, Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions).
- Provides oversight of DM CRO/service providers (e.g. reviewing vendor SOPs, invoices).
- Monitors the progress of all DM activities for the project to ensure project timelines are met.
- Executes and/or distributes DM metrics, listings, and reports, as required.
- Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed.
- Proactively identifies potential systemic and study issues/risks and recommends/implements solutions.
- Ensures the accuracy and completeness of the clinical data collected during a clinical trial.
- Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
- Demonstrated leadership quality and superior organizational and interpersonal skills.
- Requires in-depth knowledge of clinical DM principles, clinical trials process and regulatory requirements.
- Excellent verbal/written and interpersonal skills required for working successfully in a cross- functional team environment.
- Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email.
- Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
- Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint).
- Knowledge of industry standards (CDISC, SDTM, CDASH).
- Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
- Proven ability to work both independently and in a team setting.
- Bachelor degree in Life Sciences, Computer Sciences, Mathematics, or health-related field.
- 8+ years of DM experience in the pharmaceutical or biotechnology industry; depth and exposure to DM related tasks considered in lieu of minimum requirement.
- Supervisory experience desired.
- CRO management experience desired.
- Prior oncology/hematology experience highly desirable.
To apply for this position, please send your resume to email@example.com
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. This document may be changed at management’s discretion.
Acerta Pharma is an equal opportunity employer. Acerta Pharma will consider all qualified applicants for employment, and all qualified contractors for Acerta Pharma contract positions, without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. Acerta Pharma only employs individuals, and engages contractors, with the right to work in the country/ies where the role is based.
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