What are the responsibilities and job description for the Senior Clinical Data Manager - Remote position at Penfield Search Partners?
Contact: Neisha Camacho/Terra Parsons –
No 3rd Party Agencies
Job Description: The Clinical Data Manager manages all aspects of the clinical trial data management process from study start up to post database lock for assigned studies. Serves as a key contributor to the success of the Data Management team. Oversee multiple large and complex studies, performing and delegating tasks as appropriate. Effectively interact with sponsors and manage vendors.
Responsibilities:
- Primary Data Management contact and/or contributor for assigned clinical projects, ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
- Provide input into timelines. Ensure that clinical data management deadlines are met with quality.
- Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.
- Conduct database build UAT and maintain quality controlled database build documentation.
- Specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc.
- Ensure proper completion of QC and UAT of EDC tools and modules, including database testing, data export testing, and testing of custom programming.
- Coordinate with vendors to ensure efficiency and quality of electronic data receipt, integration, and reconciliation.
- Troubleshoot technical issues as appropriate.
- Perform SAE/AE reconciliation.
- Perform pre-lock and data lock tasks.
- Participate in vendor and internal meetings as required, providing status updates and advising on best practices as appropriate.
Requirements:
- BS in a clinical or scientific discipline with 9 years direct clinical data management experience in a pharmaceutical, academic, or CRO environment.
- The successful candidate will be an agile thinking and collaborative individual with both a strong track record of hands-on clinical data management experience and leadership capabilities.
- Expertise with EDC systems, such as Medidata Rave, InForm, Medrio
- Excellent organizational and time management skills
- Strong collaboration and leadership skills
- Working knowledge of industry standards, such as CDISC/SDTM
- Basic understanding of SAS, SQL and/or other clinical programming
- Understanding of application of clinical data coding classification systems, e.g., MedDRA, WHO-Drug
- Good working knowledge of GCP and ICH guidelines, and Good Clinical DM practices
- Plans, schedules, and monitors work to meet time and quality targets.
- Ability to absorb, translate and communicate complex matters.
- Excellent written and verbal communication
- Must be able to interact and liaison effectively with people at all levels of the organization and with external vendors, investigators, site personnel, etc.
