Johnson & Johnson Careers
Senior Trial Manager ED&CP M/F
Issy Les Moulineaux, Haute-de-Seine
Clinical Trial Coordination
Requisition ID: 1805665446W
The Early Development & Clinical Pharmacology (ED&CP) Trial Manager II (TM II) is responsible for the local management of a trial in one or more countries and to deliver quality data and trial documents/records that are compliant with assigned clinical protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Health Care Compliance requirements (HCC) and local regulatory requirements.
He/she acts as the primary point of contact at a country level for assigned studies.
The Sr. TM performs the Local Trial Manager (LTM) tasks including operational oversight of assigned
protocol(s) from start-up to database lock and closeout activities as described in GCO procedural documents.
The Sr. TM performs the GCDO Trial Leader (GTL) tasks as described in GCO procedural documents for ED&CP
studies which follow the ED&CP hybrid oversight model.
The Sr. TM may perform the Site Manager (SM) tasks as described in GCO procedural documents for ED&CP
The Sr. TM actively contributes to process improvement initiatives, training and mentoring of TMs, SMs and Clinical Trial Assistants (CTA).
Compared to a TM I, a Senior TM is often assigned to multi-center complex protocols and can work across Phase 0 – IIa studies in multiple therapeutic areas as needed to drive business needs.
1. Besides the LTM tasks, a Sr. TM may also be responsible for GTL and SM tasks depending on the studies assigned. For the GTL and SM tasks reference is made to the Job Description for the ED&CP GTL and SM and the GCO Procedural Documents
2. Collaborates with the FM for performing study feasibility and site assessments, providing recommendation of suitable sites for selection to participate in the trial according to ED&CP decision tree. Ensures appropriate follow-up of pre-trial visit activities. Collaborates with the GPL (GCDO Program Leader), GTL, country TMs (if applicable), FM and other study team members to select final sites list.
3. Contributes to the development of study management documents at a country level or initiates development of these documents for trials which follow ED&CP Hybrid Oversight Model.
4. Leads and coordinates local trial team(s) activities in compliance with GCO SOPs, other procedural documents and applicable regulations. Leads project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget, including but not limited to: development
Version 1.0 dated 18 October 2017 (FINAL) For Internal Use Only Job ID: 10001468: Specialist 4, Clinical Trial Admin/Oper (PG 26) Page 2 of 4 of trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting (if applicable).
5. Ensures that all Serious Adverse Events (SAE)/Product Quality Complaints (PQC)/Suspected Unexpected Serious Adverse Reactions (SUSAR) are reported within reporting timelines and documented as appropriate.
6. Maintains and updates trial management systems. Uses study tools and management reports/dashboards available to analyse trial progress
7. Monitors country and overall study progress (if applicable) and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to GPL, GTL and study management teams e.g. ensures appropriate documentation and follow-up related to protocol issue escalation.
8. May submit requests for vendor services and may support vendor selection. Reviews and approves site and local vendor invoices as required.
9. May assist Contract & Grant (C&Gs) for negotiation of trial site contracts and budget. Is responsible or collaborates with Clinical Forecasting & Analytics for forecasts and management of GCO budget to ensure accurate finance reporting and trial delivered within budget. Adheres to finance reporting deliverables and timelines.
10. Accountable for set-up and conduct of Investigator Meetings (either local or multi-country) if applicable and collaborates with SM for site initiation visits.
11. Conducts trial team meetings and provides or facilitates TM/SM training when needed and build key competencies (i.e. implementation of study amendment-and changes in study related processes).
12. Reviews and approves Visit Reports submitted by SM within procedural timelines; identifies issues and trends across a trial/project and escalates deviation/issues to the GTL and FM as needed. Supports implementation of ARBM (Analytical risk based monitoring) model as applicable.
13. Supports SM in setting up action plan in case data entry timelines are not respected.
14. Ensures coordination of study supplies at country level or study level as applicable and ensures that clinical drug supplies are appropriately handled, administered and stored in strict adherence with investigational product preparation and administration guidelines in collaboration with SMs, PIPS (Pharmacy Investigational Product Specialist) and SIPS (Site Investigational Product Specialist).
15. Monitors sites recruitment and sets up an action plan in collaboration with SM in case of non-enrolling sites
16. Prepares master informed consent and country specific informed consent(s) in accordance with GCO procedural document/templates. Reviews and manages site specific informed consent forms in accordance with GCO SOPs, other procedural documents and applicable regulations.
17. Organizes IEC/HA approvals, if applicable and ensures that the trial is in compliance with local regulatory requirements
A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
Minimum four years of clinical trial management experience (in addition of site monitoring experience) is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility. Previous experience in Early Development/Clinical Pharmacology trials is preferred.
Experience in mentoring/coaching and providing training to TM/SM/CTAs.
Strong leaderships skills, ability to lead initiatives/small team.
Specific therapeutic area experience/knowledge may be required depending on the position. Early development experience is preferred. Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills required.
Proficient in speaking and writing the country language and English language. Excellent written and oral communication skills. Shows leadership skills.
Willingness to travel with occasional/regular overnight stay away from home depending on the region.
Flexible mindset and ability to work at a fast paced within small exploratory international study teams in a fast-changing environment.
Ability to work on multiple trials in parallel in different disease areas.
France-Haute-de-Seine-Issy Les Moulineaux
Janssen Cilag S.A.S. (7825)
Clinical Trial Coordination