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Clinical Research Manager - Belgium
Johnson & Johnson (company)
Posted on : 08 March 2017
Firstly, the CRM has experience in PBMC Harvesting and cryo-preservation. In concertation with the company immunology experts, the CRM:
- Identifies and selects a vendor that oversees a global network of Blood-PBMC processing labs Negotiates terms & conditions and price, and contracts the vendor that manages a global network of Blood-PBMC processing labs in collaboration with Procurement Co-supervises training and (re)qualification of (newly selected) Blood-PBMC processing labs, including dry-runs / pilot studies and quality assessments of cryo-preserved PBMCs Co-audits Blood-PBMC processing labs within the global lab network Supervises the logistical set-up and management (by the vendor) of
- shipments of blood samples, from blood-collection sites to Blood-PBMC processing labs
- shipments of cryo-PBMC samples, from Blood-PBMC processing lab to Immunology lab
- storage of cryo-PBMC samples (Liquid Nitrogen)
- inventory of cryo-PBMC samples
- Safeguards the application of one uniform PBMC Processing procedure – selected by the sponsor - across the different Blood-PBMC Processing labs
Secondly, in concertation with company immunology experts, the CRM:
- Identifies and selects a vendor that performs T-cell response assays such as ELISpot and ICS Negotiates terms & conditions and price, and contracts a vendor that performs T-cell response assays such as ELISpot and ICS in collaboration with Procurement Follows up on the qualification of the Immune-assays that will be applied in interventional studies Supervises the logistical set-up and management (by the vendor) of
- storage of cryo-PBMC samples (Liquid Nitrogen) in the Immunology Lab
- analyses of cryo-PBMCs in pre-defined immune-assays
- Organizes and supervises the (e)Data Transfers from the Immune-lab to the sponsor Organizes and supervises the statistical analyses of data generated in immune-lab Ensures a final report is created by the vendor and shared with the Clinical Development Team as appropriate according to the pre-defined timelines
Thirdly, the CRM has experience in management of Clinical Studies. The CRM provides guidance and leadership to representatives of various internal and vendor functions involved in the initiation, conduct/execution and/or finalization of Early Development (ED) and Phase IIa studies. The CRM may be assigned to one or more of the below listed responsibilities:
- Ad-hoc member of CDT Sub-team (ED, Phase IIa)
- Gives study-design related input/feedback, in collaboration with Disease Area Scientist(s) and other internal partners
- Reports trial status, progression and operational issues to the CDT and its Sub-teams as appropriate
- Full member of the Clinical Working Group or Study Team (per study) Participates in the identification and selection of clinical sites and Service Providers
- Leads Site feasibility and vendor selection
- Closely follows up on timely execution and finalization of contracts/work orders with sites and (E2E) vendors, in partnership with company R&D Procurement and reviews study contract proposals for approval, in collaboration with budget owner
- Participates in or leads Clinical Working Group (study team) Meetings including those with the vendors.
- Coordinates and oversees study-related actions of the different individual vendor partners contributing to the study, end-to-end
- Assures timely submission to Competent Authorities (i.e. HA and EC/IRB), before, during and after conduct of the study, in collaboration with experts of relevant functional areas of our company or of the E2E vendor
- Assures that the study-related info is entered and maintained current in the national and international Clinical Trial Data Bases as required per company Procedures.
- Oversees interactions / organizes coordination meetings with external vendors involved in the study; coordinates and chairs the meetings as needed.
- Assures escalation and documentation of issues (site issues, central issues etc.)
- Assures study timelines are met, as agreed upon with the CDT
- Develops, tracks and keeps oversight on study budget and keeps study budget within pre-agreed limits
- Assures overall quality of the study and adherence to study protocol, GCP and applicable SOPs
- Follows-up on changes in scope, timelines, budget and quality and reports in due time to relevant parties and CDT (or sub-team)
- Organizes Medical Data Review meetings and Dose Escalation Meetings, if applicable
- Performs co-monitoring visits when desired/required
- Ensures timely filing and archiving of study related documents (study binders) and electronic records (such as email correspondence); Ensures the TMF is inspection ready
- Organizes or participates in a trial evaluation / lessons learned meetings with relevant team members (internal, external, site staff, as deemed appropriate)
- Ensures cross-trial consistency in management and conduct of studies
- Development of study documents:
- Contributes to generation and review of the protocol synopsis and the full protocol.
- Manages contracted medical writers to deliver the protocol synopsis and the full protocol, in collaboration with assigned company lead Medical Writer
- Drafts ICF for review and ensures finalization of the master template for the assigned study
- Reviews and approves the Project Plan generated by the CRO
- Contributes to the review of Case Report Forms and participates in UAT as needed
- Reviews and/or approves monitoring plan and other plans created by the vendor(s)
- Reviews the Pharmacy Manual as applicable
- Reviews Bioanalysis Manual and (Central) Lab Manual (if applicable)
- Reviews Safety Documents such as Medical Review Plan and Safety Management Plan as applicable
- Reviews and coordinates review of Data Management documents and Statistical Analysis Plan as applicable
- Contributes to and reviews Clinical Study Report
- Reviews study abstracts, study posters, study manuscriptsCross-Study Responsibilities
- Contributes to the development and improvement of departmental procedures and processes for ED and Phase IIa studies, in the scope of the company’s efforts towards continuous quality improvement and harmonization, where required.
- Assist in SOP development as required.
Education and experience:
- Master in Life Science – such as pharmacy, biology, biotechnology, etc
- Experience in working in a biology / biotechnology / cell culture lab
- Experience in Good Laboratory Practice
- Experience in early clinical development, with emphasis on Clinical Study Execution and Management, as demonstrated by the previous experience in clinical study monitoring and clinical operations support.
- Team Work experience
- Experience in auditing and qualifying laboratories is an asset
- Experience in working in a matrix-structured organization is an asset
- PBMC Isolation + Cryo-preservation, ELISpot, ICS (Intracellular Cytokine Staining) and cytokines analyses is a must
- Good Laboratory Practice, Good Clinical Practice and ICH Guidelines is a must
- Early Development, Phase I and Phase II environment is a must
- Immunology (scientific knowledge) is a must
- Hepatitis B or Respiratory Disease (scientific knowledge) is an important asset
- Biomarkers is an asset
- Vaccine Development is an asset
- Excellent project management /organizational/logistical skills
- Solid scientific reasoning skills
- Excellent people management and decision making skills
- Fluent in written and spoken English with good presentation skills
- Good sense of cultural sensitivities and differences
- Ability to identify priorities and work under pressure to meet deadlines
- Ability to advise, persuade and negotiate with external parties in a supportive and constructive fashion
- Willingness to travel abroad, including trans-Atlantic (10-20%)
- Willingness and ability to partially adjust work hours in order to facilitate trans-Atlantic collaborations (with USA, Asia-Pacific, …)
- As an employee we consider you as our most valuable asset. We take your career seriously.
- As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
- Through e-university, on the job training, various projects and programs, we ensure your personal growth.
- Our benefits make sure we care for you and your family now and in the future.