Janssen-Cilag is recruiting for an IIS (Investigator Initiated Studies) Trial Manager, Medical Affairs Operations, located in Neuss, Germany.
The position is accountable for the operational oversight of assigned Investigator Initiated Studies (IISs) and responsible for local management of IISs in one or more countries from the beginning to close-out activities assuring that IIS study progress, safety reporting, drug and financial management adheres to the contract and all applicable Policies, SOPs, Work Instructions and regulatory requirements.
This position collaborates externally with IIS Sponsor-Investigators, and internally with the IIS Trial Manager Lead (IIS TML), Global Development functions, Local Operating Company Medical Affairs personnel, Healthcare Compliance (HCC/HCBI), J&J Legal, pharmacovigilance and other areas as appropriate.
The Trial Manager (TM) may perform Global Trial Lead (GTL) tasks as described in Global Development procedural documents for IISs for which no GTL has been assigned.
- Full life-cyle responsibility for assigned IISs in accordance with all applicable regulations/guidelines and relevant Janssen Policies, SOPs
- Acts as the central contact for designated project communications, correspondence and associated documentation.
- Maintains communication with Sponsor-Investigator and staff during all phases of the IIS regarding study progress, issue identification/resolution, contractual matters including payments and collection of required documents.
- Monitors study progress, initiates corrective and preventative actions when the trial deviates from plans, communicates study progress and issues in support of Medical Affairs/R&D Study Responsible Physician/Scientist (SRP/SRS).
- Ensures that contracts, budgets and payment schedules are prepared alongside with IIS contract requirements and HCC/HCBI considerations.
- As the need arises, in consultation with appropriate representatives of the operating company, ensures required contract amendments are prepared.
- Ensures that required safety information (e.g. SAEs/AEs, PQCs) are reported and processed according to all applicable SOPs.
- Accountable for budget oversight and forecasting.
- Communicates budget discrepancies or payment delays with rationale to Operating Company representatives and the IIS TML.
- Accountable for drug management (e.g. projections, requests) for assigned IISs.
- For IISs not progressing to agreed contract timelines and/or budget ensures an action plan is implemented and regular status updates are provided to the IIS TML and SRP/SRS.
- Maintains documentation of assigned IIS in TMF and performs periodic review to ensure accuracy and completeness.
- Maintain and updates applicable Janssen systems including, but not limited to, CTMS, TMS, SharePoint, etc. Uses study tools and management reports available to analyze study progress.
- Develops strong therapeutic knowledge to support roles and responsibilities.
- Establishes and maintains excellent working relationships with external partners, in particular investigators, study trial coordinators and other site staff, internal partners, including Medical Affairs and R&D Therapeutic Areas.
- Contributes to process improvement initiatives and training and mentoring or other IIS team members.
- Participates in preparing for or conducting Health Authority inspections and internal audits.
- 4-year University/Bachelor’s degree or equivalent is required.
- A degree in health sciences, Nursing or related scientific field is preferred.
- Minimum of 5 years clinical research operations experience in the pharmaceutical industry or CRO (Clinical Research Organization); however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
- Proficient in speaking and writing German and English language. Good written and oral skills.
- Proven understanding of the drug development process including ICH/GCP and local regulatory requirements.
- Confirmed leadership skills are required. Flexible attitude and ability to work in a fast-pace environment.
- Ability to work on multiple IISs in parallel in different therapeutic areas is required.
- Requires clinical research operational knowledge, project planning/management and communication skills.
- Should have experience with and be able to participate on global, regional, or local teams in a virtual environment.
- Ability to actively participate and contribute to the productivity and cohesiveness of the team.
- Good analytical skills and solution oriented, actively seeking input from others.
- Willingness to travel occasionally with overnight stays depending on region.
- Experience in managing investigator initiated studies and study types (interventional, non-interventional and/or registries) is preferred.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Germany-North Rhine Westphalia--
Janssen-Cilag Germany (8000)