Senior Clinical Data Manager
Department Name: Data Management
Objective of Position
The Senior Clinical Data Manager (Sr. CDM) is responsible for all aspects of the data management process from the development of project documentation, system set-up, UAT through database lock. This person may have project level oversight of junior data managers and/or Clinical Data Associates (CDAs). The core duties and responsibilities of the Sr. CDM are delineated below.
Essential Duties/ Responsibilities
- Participates in the development, review and implementation of departmental SOPs, templates and processes
- May have project oversight of internal clinical data associates, and data managers
- Provide feedback and task assignment
- Supports budget and resource planning across assigned projects
- Contributes to technical infrastructure of data management
- Participates in CRO/vendor selection process for outsourced activities
- May participate in department or cross-functional initiatives
- Represents data management in study team meetings
- Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines
- Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols)
- Executes and/or distributes data management metrics, listings, and reports, as required
- Oversight of data management CRO/service providers
- Monitors the progress of all data management activities for the project to ensure project timelines are met
- 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 study issues/risks and recommends/implements solutions
- Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal
- Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables
- Requires solid knowledge of clinical data management 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 or in a team setting
- Bachelor degree in Life Sciences, Computer Sciences, Mathematics, or health- related field
- Minimum 7 years of DM experience in the pharmaceutical or biotechnology industry, depth and exposure to DM related tasks considered in lieu of minimum requirement
- CRO management experience desired
- Competence in SAS programming a plus
- 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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