PURPOSE OF THE ROLE
The CDM is responsible for all data management aspects of the assigned clinical studies from initiation till closure ensuring that clinical data completeness, accuracy and consistency meet the standards of quality for analysis and reporting to regulatory bodies, compliant with the local and global regulations.
ROLES AND RESPONSIBILITIES
THE CDM WILL:
Ø Take a leadership role with the CRO, clinical study team and other internal and external partners to establish, align and conform data management expectations for the assigned trials.
Ø Set quality expectations and timelines for data management deliverables and will regularly follow up on data management milestones
Ø Ensure compliance with SOPs, company policies and regulatory requirements from trial start-up to trial close-out.
For the assigned trial(s) the CDM may be asked to:
Ø Participate in CRO selection and contract negotiations together with the clinical study team and the Vendor Management representative
Ø Contribute to development of the protocol for the sections relevant for DM (feasibility of data collection, adherence to industry and standards, (interim) locks) and/or review of protocol versions
For the assigned trial(s), the CDM will:
Ø Oversee all deliverables of activities outsourced to CROs as outlined in the SOW and described in the Data Management Trial Oversight plan, including, but not limited to:
o Creation of data collection tools (EDC, DTAs for 3rd party vendors, EDC integrations)
o Creation of essential documents (DMP, UAT documents)
o Creation of submission ready clinical data package per regulatory agencies requirements.
o Creation of archival package of clinical data per requirements
Ø Oversee all activities related to Data Management:
o Ensure that Data Management essential documents are written in a timely manner and of such quality to allow the evaluation of the conduct of a trial and the quality of the data produced
o Facilitate cross-functional review by applicable stakeholders of essential documents and data management deliverables
o Keep track of project plan, budget, metrics and KPIs. Adjust project plan as needed in consultation with Data Management CRO and Clinical Team.
Ø Create Data Release Plan in consultation with applicable stakeholders and oversee Data Releases (such as for DSMB/IDMC, interim and final locks, updates after lock) as per plan and blinding rules.
Ø Participate in User Acceptance Testing Activities for the applicable Data Collection Tools
Ø Perform adequate Quality Control for data completeness and accuracy
Ø Contribute to the development in lessons learned and shares best practices within the trial and department.
The CDM will also participate in activities other than study-related:
- Lead/participate in initiatives on process improvement
- Participate in regulatory inspections and company audits
SKILLS AND COMPETENCIES
Ø Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM best practices
Ø Experience with tools and systems for managing clinical studies (study progress and metric systems, eCRF systems, metadata repositories)
Ø Eye for detail, analytical skills
Ø Able to work effectively within a team matrix as well as independently
Ø Strong communication and interpersonal skills
Ø Fluent in English (written and spoken)
EDUCATION, EXPERIENCE AND QUALIFICATIONS
Ø Bachelor's degree or Master's degree - medical, para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.), mathematics or equivalent by experience
Ø Demonstrated experience in Clinical Data Management
Ø Experience in managing CROs and vendors is a plus
Ø Biotech experience is a plus
Ø Auto-immune and/or orphan disease clinical study background is a plus
Regarding this role, Kelly Services acts as the official mediator. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement.
In keeping with the Law regarding discrimination and equal opportunity in Belgium, Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.
Met betrekking tot deze functie fungeert Kelly Services als officieel bemiddelaar. Wanneer je de beslissing maakt om op deze functie te solliciteren zullen jouw gegevens in overeenstemming met Kelly's Privacy Statement worden verwerkt.
Met oog op de wetgeving tegen discriminatie en het gelijke-kansenbeleid van kracht in België, verwelkomt Kelly Services sollicitaties van iedere geschikte kandidaat, ongeacht etniciteit, geslacht, beperking, religieuze overtuiging, seksuele geaardheid of leeftijd.
Concernant ce rôle, Kelly Services agit en tant que médiateur officiel. Lorsque vous décidez de postuler ce poste, vos informations personnelles seront traitées conformément à la déclaration de confidentialité de Kelly.
Conformément à la loi sur la discrimination et la politique d'égalité des chances en Belgique, Kelly Services accueille les candidatures de tous les candidats éligibles, quels que soient leur origine ethnique, leur sexe, leur handicap, leur religion, leur orientation sexuelle ou leur âge.