Description
Clinical Data Manager - Belgium
Langauges: English ONLY!
Skills and 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 (ie CDISC, SDTM, CDASH, etc.)
- Knowledge of technology platforms for data exchange
- Outstanding written and oral communication skills
- Negotiation skills
Key Project Management Skills
- E ffectively prioritizing and managing multiple tasks simultaneously
- Excellent interpersonal skills
- Excellent problem solving and decision making skills
- Subject matter expertise available for internal staff/external partners
Responsibilities:
- 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)
- With the trial customer, CRO and other functional partners
. Gathers content and integration requirements for eCRF and other data collection tools
. 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
- Prepares or reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency; ensures compliance with regulatory guidelines and the documentation Matrix
- Ensures Real Time inspection readiness of all IDS deliverables for the trial; Participates in Regulatory Agency and internal audits as necessary
- 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
Please send your CV.
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