Position Summary:
The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.
Essential functions of the job include but are not limited to:
- Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
- Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
- May perform quality control of data entry
- Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
- Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
- May assist in building clinical databases
- Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
- May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
- Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
- 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
- Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
- Run patient and study level status and metric reporting
- Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
- 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
- May assist with SAS programming and quality control of SAS programs used in the Data Management department
- 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
- May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
- Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
- May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
- May review Request for Proposals (RFP), proposals, provide project estimates
- Provide leadership for cross-functional and organization-wide initiatives, where applicable
- Trains and ensures that all data management project team members have been sufficiently trained
- Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
- May present software demonstrations/trainings, department/company training sessions, present at project meetings
- May require some travel
- Perform other duties as assigned
Qualifications:
Minimum Required:
- Bachelors and/or a combination of related experience
Other Required:
- 10+ years’ experience
- 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
Preferred:
- Experience in a clinical, scientific or healthcare discipline
- Dictionary medical coding (MedDRA and WHODrug)
- Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
- Oncology and/or Orphan Drug therapeutic experience
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