Johnson & Johnson – Janssen, the pharmaceutical division of Johnson & Johnson, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neurosciences & analgesia, dermatology, infectious diseases and metabolic diseases in India. Driven by a strong commitment to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world. Janssen recognizes the impact of serious conditions on people’s lives, and aims to empower people through disease awareness, education and access to quality care in six therapeutic areas.
Job Title : Trial Manager
Requisition ID : 1700181638W
Department : Global Clinical Operations (GCO)
Location : Greater Mumbai, India
- Reporting to the MAO Clinical Program Leader (CPL), or MAO Global Trial Manager (GTM), or MAO TM functional Manager, the MAO TM is accountable for leading with success the execution of local company data generation activities in one or more countries for project(s) assigned by the Clinical Program Leader, Functional Manager, or Clinical Operations Head.
- This includes all project activities starting from Request for Services and high level budget estimate through protocol development to delivery of final Clinical Study report (CSR) or other deliverable(s), according to planned milestones, within budget, and with high quality standards per company procedures and regulatory requirements.
- The MAO TM serves as the single point of end-to-end accountability for assigned project(s); leading the Study Management Team (SMT) for local studies, interfacing with the Clinical Teams, GCDO fucntions, stakeholders from local Medical Affairs or other internal trial sponsors, external service providers e.g. contract research organization (CRO) and/or other J&J enterprise sectors, as applicable.
- The MAO TM performs tasks similar to the MAO Global Trial Manager (GTM) and in some instances to the Global Clinial Operations-Local Trial Manager (GCO LTM) for assigned local company data generation activities as described in Global Clinical Development Operations (GCDO) procedural documents.
- This includes all project activities starting from protocol development to delivery of final Clinical Study report (CSR) or other deliverable(s), as well as driving issue identification and resolution and contingency planning, all according to planned milestones, within budget, and with high quality standards per company procedures and regulatory requirements.
- Leads the SMT as the single point of accountability for end-to-end project management including high level budget estimate, protocol development, trial set-up, execution, close-out, analysis and reporting.
- For projects executed in-house, the TM will oversee and support Site Managers, GCO-LTM (if assigned) and other team members in the daily operational activities in line with country specific regulations and internal processes, if required.
- For projects outsourced to a CRO, the TM will oversee and monitor the CRO’s performance on all contracted services.
- Prepares or contributes to high level budget estimate in response to Request for Services followed by detailed budget proposal.
- Leads vendor assessment and selection in consultation with appropriate representatives of the operating company.
- Ensures accurate project budget management and tracking according to plan. Updates project account with scope changes, if any.
- Is accountable for delivery of assigned trials within agreed/projected life of trial budget. Ensures accurate trial budget management and tracking, updates for scope changes and reconciliation of costs, as applicable. Responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
- Tracks project progress against planned timelines. Monitors patient recruitment rate to ensure that target enrollment will be met across the allocated regions/countries.
- Provides regular status updates to SMT, project owners and Clinical Team members. Ensures required reports are generated and available for real time tracking of project status.
- In coordination with the Functional Manager/CPL, Study Responsible Scientist/Physician (SRS/SRP) and/or Clinical Leader, the TM provides adequate project-specific training to the GCO or CRO teams and to the site staff. Works with GCO/CRO staff in the set-up and coordination of Investigator Meetings, if applicable.
- Maintains project compliance within all applicable Health Authority (HA) regulations, guidelines, internal SOPs and processes. Ensures quality oversight of assigned projects utilizing the available tools so that the project is in a constant state of inspection-readiness. Participates in preparation for, and conduct of, HA inspections and internal Quality Assurance (QA) audits.
- Identifies and proactively manages issues in a timely manner.
- Communicates regularly with the Functional Manager/CPL/COH.
- Escalates issues and manages risks related to resources, timelines and budgets.
- Build proposal for Action Plan(s) with the SMT to implement solutions on a project level.
- Internal contacts: Functional Manager, CPLs, COHs, GTMs, GTM-CTAs, GCDO functions, GCO Country teams, Country Medical Affairs teams, SMTs, , Legal, Finance, QS, PDMS, Regulatory Affairs, Quality Management & Training group, Quality Assurance group, Procurement (JRP), Project Owners and other J&J enterprise sectors, as applicable.
- External contacts: external service providers, clinical investigative sites and their research staff.
Education & Experience Requirements:
- Bachelor’s degree or equivalent required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Minimum of 5 years of clinical trial experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
- Clinical operations knowledge, project management and proficient communication skills are required. Computer literacy is also required.
- Excellent decision-making and strong financial management skills are essential for this position.
- Effective study team leadership skills and proven ability to foster team productivity and cohesiveness. Flexibility and ability to manage study teams in a virtual environment are needed.
- Ability to work on multiple projects in parallel in different therapeutic areas is required.
- Experience in managing all study types (interventional, non-interventional, registries) is preferred.