Global Data Manager
Paul De Challans is recruiting for a Global Data Manager to join a company in the Pharmaceutical industry at their site based in Belgium on a contract basis.
The main purpose of the role will be: Project/Department Description Biostatistics & Programming CoE Tasks -
- Accountable for the project management, complete oversight and timely delivery of clinical trial data and documentation according to agreed upon timelines and quality expectations
- Is the liaison between the trial customer, the CRO(s) and other functional partners(s) for all issues related to data for assigned trial(s)
- Ensures Inspection Readiness of all data management deliverables and ensures adequate archiving of data management documentation
- Is a member of SMT and Clinical Working Group(s) and leads the trial subteam(s)/workstream(s) for data management deliverables (e.g., eCRF design, Database Lock)
- Participates in or leads a non-trial related project within IDS or cross functionally
- Liaises continually between the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s)
- Establishes conventions and quality expectations for clinical data - Establishes expectations for dataset content and structure
- Sets timeline and follow-up regularly to ensure delivery of all Data Management milestones
- Performs trial level oversight controls as described in the oversight plan, QC process and work instructions - Participates in User Acceptance Testing and performs trial data Quality Control.
- Plans and tracks content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival; ensures deliverables are on time and within budget
- Supports the assigned clinical working group(s) to ensure that IDS and TA trial needs and deliverables are met - Provides input to the DML on trial initiation needs (scope of work, budget, resources), and CRO selection in non-standard situations as appropriate
- Identifies and communicates lessons learned, best practices and frequently asked questions at trial level
- Identifies and participates in process, system, and tool improvement initiatives within IDS
- Presents and trains at investigator and monitor meetings - Participates in or leads non-trial/non-program projects based on specific expertise
- Participates in internal/external staff mentoring and training Profile -
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
BS/BA or equivalent work experience.
At least 3 years of experience in Clinical Drug Development within the Pharmaceutical Industry or related Industry with proven track record; Data Management experience required.
- Thorough knowledge of the protocol
- Understanding of current clinical drug development processes
- Knowledge of applicable international guidelines regarding Data Management of clinical trials
- Relevant System / technical knowledge - Knowledge and understanding of current industry standards (i.e. CDISC , SDTM , CDASH , etc.)
- Knowledge of technology platforms for data exchange
- Knowledge of electronic data capture (eDC) systems, preferably Medidata Rave
- Outstanding written and oral communication skills
- Negotiation skills - Key Project Management Skills
- Effectively prioritizing and managing multiple tasks simultaneously
This is an excellent opportunity to join a global pharmaceutical company
For more information or to apply for this position, please contact Paul De Challans on 0114 283 9956 or email email@example.com. Or click on the link below.
CK Clinical is an Equal Opportunities employer who 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 campaign. Entitlement to work in the EEA is essential. Please quote reference CL30119 in all correspondence.