CLINICAL RESEARCH MANAGER

The responsibilities of the CRM follow the ED & CP (Clinical Pharmacology) Hybrid Trial Oversight Model, effective as of 15th of September 2013 CRM Model (single-site, single-country Phase0, ED and PhaseIIa studies). I.e. Study content and operational study oversight resides at ED Physician, scientist and CRM.

As Clinical Research Manager, you will provide guidance and leadership to representatives of various functional areas involved in the initiation, conduct/execution and finalization of Phase0, Early Development (ED) and PhaseIIa studies and keep total oversight of the end-to end activities (from writing of protocol synopsis till review of Clinical Research Report (CRR)) related to the conduct of such Phase0, ED and PhaseIIa studies.

Your responsibilities include:

Full member of Early Development Disease Clinical Team (Phase0, ED, PhaseIIa):

• Give study-design related input/feedback, in collaboration with Disease Area Scientist(s) and other members of the Clinical Team
• Report trial status, progression and operational issues (related to recruitment, timelines, pharmacokinetics, pharmacodynamics, safety, quality, …) in the Clinical Team

Leader of Clinical Working Group:

• Lead Site feasibility and participate in site selection and vendor selection
• Closely follow up on timely execution and finalization of contracts/work orders with commercial sites and vendors, in partnership with Janssen R&D Procurement and review study contract proposals for approval, in collaboration with budget owner
• Schedule and chair recurrent Clinical Working Group Meetings, which is an internal meeting with representatives of supporting J&J clinical departments (PK, Bioanalysis, Biostatistics, Medical Writing, Data Management, Pharmacogenomics, Regulatory Affairs, Medical, etc), who will be mandatory or optional invitees, depending the stage the study is in
• Coordinate and oversee study-related actions of the different functional areas
• Assure 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
• Assure entry of study-related info into national and international Clinical Trial Data Bases, if deemed necessary, based on internal SOPs and Clinical Team decision
• Manage interactions / organize coordination meetings with external parties (vendors) involved in the study
• Assure escalation and documentation of issues (site issues, central issues etc)
• Assure study timelines are met, as agreed upon with the clinical Team
• Develop, track and keep oversight on study budget and keep study budget within pre-agreed limits
• Assure overall quality of the study and adherence to study protocol, GCP and J&J SOP requirements
• Follow-up on changes in scope, timelines, budget and quality and report in due time to relevant parties and Clinical Team
• Organize Medical Data Review meetings
• Perform co-monitoring visits when desired/required
• Ensure timely filing and archiving of study related documents (study binders) and electronic records (such as email correspondence)
• Organize or participate in a trial evaluation / lessons learned meetings with relevant team members (internal, external, site staff, as deemed appropriate)
• Ensure cross-trial consistency in management and conduct of studies

Development of study documents:

• Write Protocol Essentials Document (PED), Protocol Synopsis (Phase0, ED, PhaseIIa studies)
• Participate in Protocol Synopsis Review Committee (SRC) Meeting and co-assure the implementation/incorporation of recommendations from such committee
• Write Protocol (“simple” Phase0 studies)
• Review Protocol (“complex” Phase0 studies, ED, PhaseIIa studies), but assume document owner role (i.e. PPOC for document reviewers and manager of review comments)
• Participate in Protocol Review Committee (PRC) Meeting and co-assure (together with MW’er, if applicable) the implementation/incorporation of recommendations from such committee and from IEC/IRB and regulatory agencies
• Review Protocol Amendments
• Contribute to Trial Plan
• Contribute to the review of Informed Consent Forms
• Review Investigational Material Packaging Agreement (IMPA) and Medication Dispensation Manual (if applicable)
• Review Bioanalysis Manual and Central Lab Manual (if applicable)
• Review Safety Documents, such as Medical Review Plan, Safety Monitoring Plan, etc if applicable
• Review Data Management documents
• Review study abstracts, study posters, study manuscripts

Cross-Study Responsibilities:

• Contribute to the development and improvement of departmental procedures and processes for Phase0 studies, in the scope of the company’s efforts towards continuous quality improvement and harmonization, where required.
• Contribute to the development and improvement of departmental procedures and processes for ED and PhaseIIa studies, in the scope of the company’s efforts towards continuous quality improvement and harmonization, where required.
• Assist in SOP development, if required.

• You have a university degree (Bachelor, Master, PhD) medical or paramedical (pharmacy, biology, veterinary, etc.) or equivalent by experience
• Experience in clinical development (clinical study monitoring, clinical study management, etc.)
• You have experience in team work
• Having worked in a matrix-structured organization is an asset
• You possess the following skills: Project Management, People Management, Communication Skills, good presentation skills
• You are fluent in written and spoken English
• You can work with different Microsoft Office applicatons (Word, Excel, Power Point, Outlook)
• You have a good sense of cultural sensitivities and differences
• You possess the ability to manage several studies simultaneously and to identify priorities
• You can work under pressure to meet deadlines
• You are able to advise, persuade and negotiate with colleagues in a supportive and constructive fashion
• You have knowledge of: Medical Domain (Hepatitis, Respiratory Diseases and/or Infectious Diseases in general), Early Development and Phase I environment and Good Clinical Practice
• Knowledge of Vaccine Development and Dengue is an asset
• You are willing to travel abroad, including trans-Atlantic
• You are willing and able to partially adjust work hours in order to facilitate trans-Atlantic collaborations (with USA, Asia-Pacific, Africa, …)

You will receive an attractive salary package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop.

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