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 start-up through
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 interfaces externally with IIS Sponsor-Investigators, and
The Trial Manager (TM) may perform Global
Trial Manager (GTM) tasks as described in Global Clinical Development
Operations (GCDO) procedural documents for IISs for which no GTM has been
Accountable for the operational oversight
of assigned IISs at an operating company level from start-up (post ReCAP
approval) through receipt of the final deliverable and close-out
activities and that IISs are conducted in accordance with all applicable
regulations/guidelines and applicable Janssen Policies, SOPs and WI’s
Acts as the central contact for
designated project communications, correspondence and associated documentation
for assigned IISs.
Maintains communication with the
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 and initiates
corrective and preventative actions when the trial deviates from plans,
communicates study progress and issues to IIS team members in support of
Medical Affairs/R&D Study Responsible Physician/Study Responsible
Ensures that contracts, budgets and
payment schedules are prepared in accordance with IIS contract requirements and
HCC/HCBI considerations. As required, in consultation with appropriate
representatives of the operating company, ensures required contract amendments
Ensures that required safety
information (e.g. SAEs/NSAEs, PQCs) are reported and processed according to all
Accountable for budget oversight for
assigned IISs including forecasting.
Communicates budget discrepancies or payment delays with rationale to Operating
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
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 working relationships with external
stakeholders, in particular investigators, study trial coordinators and other
site staff, internal stakeholders, including Medical Affairs and R&D Therapeutic
University/Bachelor’s degree or equivalent is required. A degree in health sciences,
Nursing or related scientific field is preferred.
Related Experiences :
of 5 years clinical research operations experience in the pharmaceutical industry or
CRO; however, other relevant experiences
and skills may be considered by the hiring manager when considering the
Experience in managing investigator
initiated studies and study types (interventional, non-interventional and/or
registries) is preferred.
Specific therapeutic area experience
may be required depending on the position.
Should have a solid understanding of the drug development process
including ICH/GCP and local regulatory requirements.
Solid leadership skills are required.
Flexible mindset and ability to work in a fast-pace environment
Ability to work on multiple IISs in
parallel in different therapeutic areas is required.
Proficient in speaking and
writing the country language and English language. Good written and oral skills.
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
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.
Johnson & Johnson Sdn. Bhd. (8275)
Clinical Trial Administration