Clinical Data Manager
Ian Marlow at CK Clinical is looking for an experienced Clinical Data Manager for one of our clients, based in Hertfordshire to oversee vendor management.
The Clinical Data Manager is responsible for providing clinical data management support to the Clinical Operations team and/or study project, Clinical Data Management team and Biostatistics team.
Responsibilities include, but are not limited to:
- Participating in the evaluation and selection of Data Management Vendors and Independent Contractors, as needed
- Ensuring data management milestones are met according to timelines and data integrity is maintained as defined in the Data Management Plan, GCP and ICH guidelines.
- Providing status reports/updates, resolving disputes, and ensuring timely acquisition of high quality deliverables from the CROs and vendors
- Overseeing the collaboration between Vendors. Establishing and ensuring consistent data collection standards, rules and procedures, and implementing respective SOPs and Work Instructions. Actively looking for opportunities to improve timelines and deliverables within approved scope of work.
- Developing Case Report Form (CRF), electronic and/or paper.
- Developing database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
- Leading EDC database (DB) specification process.
- Developing Data Transfer Agreement(s) between external data vendors and/or central labs and reconcile electronic data transfers from vendor to Sponsor. Acting as main liaison for clinical data management issues between EMAS and any CROs, vendors (incl EDC providers) and partners.
- Supporting data collection, validation, analysis and reporting.
- Aiding in the establishment, revision, and adherence to respective standards, rules and procedures, and implement SOPs accordingly.
- Writing and/or reviewing Data Management and Validation Plans to promote clean, quality data that supports Statistical Analysis Plans and Safety reporting needs.
- Reviewing Statistical Analysis Plans and data output (e.g., tables, listings, graphs), as needed.
- Moderate experience with AE and Con Med coding.
- Overseeing the generation of data reports from data resources. Standardizing customized reports as appropriate, and overseeing the preparation and review of respective regulatory documents (e.g., safety reports).
- Ensuring an audit ready CDM environment through the overall compliance of the data management department with GCP, ICH, Federal and other local regulatory requirements, and implement respective SOPs.
- Collaborating with Regulatory Affairs & Compliance on proper validation of clinical data management software applications used by EMAS staff to collect and process clinical data.
Experience: Previous Data Management experience CCDM certification desirable and/or other demonstrated knowledge of Good Clinical Data Management Practices (SCDM).
Education: Bachelor's Degree or equivalent desired
- Advanced understanding of clinical data management in the pharmaceutical/biotech industry, including CDISC.
- Expert understanding of regulatory requirements for clinical data management.
- Experience with EDC, proficient with SAS, SQL, Excel and data reporting software.
- Ability to multitask, including initiating, maintaining, and following through on needed projects/assignments to streamline processes and enhance procedures to foster a compliant and efficient organization.
- Strong verbal and written communication skills.
- Robust computer skills including MS Office, MS SharePoint, PC/Internet environment.
- Able to travel occasionally (less than 10% of the time), including overseas travel.
For more information or to apply for the Clinical Data Manager position please contact Ian Marlow on +44 (0)1438 842969 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process. Entitlement to work in the EEA is essential. Please quote reference CL31438 in all correspondence.