Job purpose
The position is responsible for the regional coordination of clinical trial management activities for outsourced and/or collaborative trials from start-up through study closure in alignment with the Janssen Standard Operating Procedures and applicable Health Authority Regulations.
Responsibilities primarily focus on investigational site capacity building, Good Clinical Practice (GCP) implementation and quality oversight in collaboration with CRO in region, facilitate regulatory approvals in collaboration with global Regulatory Affairs; oversight of Investigational Medicinal Product (IMP) import and storage in the region; Good Participatory Practice (GPP) implementation and oversight.
Responsibilities may also include oversight of regional vendors or suppliers.
The position requires strong operational expertise and knowledge of local clinical research regulations and health care systems.
This position is a member of the Janssen team – partners with CRO/Partner Team and interfaces with other Global Development (GD) functions, Study Responsible Physician and Global Clinical Operations (GCO) or CRO/vendor staff and Study Sites (if applicable).
Reports for the project to the GD Trial Leader (GTL) and is member of the Cross-functional Trial Team, led by the GTL.
The responsibilities & the impact YOU will have:
The main duties and responsibilities of the position are:
Assesses the need to build capacity and contributes to capacity building where needed, including follow up on basic infrastructure building for site, local lab and/or local pharmacy/depot.
Demonstrates deep knowledge of global (ICH) and different local regulations and guidelines in the region, as well as Janssen Policies, SOP’s and study protocols.
Invests in relationship building with local stakeholders to strengthen and optimize the regulatory framework for clinical research including Genetically Modified Organism based IMP and Material Transfer Agreements for biological samples.
Helps Ensure appropriate safety reporting procedures are in place per Janssen Policies, and applicable local regulations, and acts as liaison to Global Medical Safety (GMS) and Local Safety Officer (LSO)
Supports Review and approval of the Local IMP label; manage local depot quality and issue handling; identify import license requirements and support IMP import.
Contribute to local GPP implementation based on central GPP guidelines, and practical GCP experience/adherence. May contribute to local community engagement strategies.
Provides sponsor oversight and Support of clinical trial execution in the region by means of:
Trial execution in the region is in compliance with Janssen SOP’s and policies, international and local regulations, and are aligned with local health care system. And protocol compliance
Participation in preparation for, and conduct of, Health Authority inspections and internal Quality Assurance audits. Support CRO/partner to ensure that trial sites are continuously inspection ready. Work with Quality Management (QM) liaisons to ensure quality oversight of assigned trial utilizing the available tools.
Reviews (On-Site Compliance) Monitoring Visit Reports submitted by the CRO and ensures action items are followed up in time and with the appropriate quality. Identify trends across countries within the region and initiate corrective actions in collaboration with CRO and Janssen internal functions.
Performs (or participates if initiated by CRO) lessons learned activities and knowledge sharing across in- house (leverage with GCO) and the outsourced protocols and with internal and external stakeholders relevant to the region.
Support the global team in Management of regional vendors and their issue handling and contribute to contingency/mitigation plans where needed.
Act as the Sponsor contact person for the local teams of the partners and/or CRO. Establish and maintain excellent working relationships with internal and external stakeholders. Demonstrates deep knowledge of protocol and procedures, adequate therapeutic area knowledge, and practical implementation in the region.
May collaborate with CRO/Partner for:
Country protocol feasibility and site feasibility assessment
Provide regional intelligence/guidance to study teams in regard to actual or forecasted CRO Out of Pocket Expenses or other vendor related expenses linked to the region and review assigned vendor invoices/spend on ad hoc basis and as applicable.
Contribute to study-specific documents to account for region specific requirements or needs, such as Monitoring Guidelines, Informed Consent Form, IMP related documentation, Blinding Plan, country and site feasibility related documents, Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan
Review and customize appropriate trial-specific training materials and requirements, making them available and appropriate to the regional monitors and site study staff and delivering training as needed. Contribute to Regional Investigator Meetings, in close collaboration CRO/Partner staff as well as GTL.
Acts as a Subject Matter Expert with regional expertise including Clinical Research Capability development by GPH, and external partners. Providing regional insights by connecting with regional stakeholders/groups.
We’d love to hear from YOU, if you have:
BS degree or equivalent required, preferably in Medical or Life Sciences (e.g., Medical Doctor, Biology, Chemistry, Biochemistry, Nursing, PharmD),
Minimum of 6-8 years Clinical Trial Management experience however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
Requires clinical research operational knowledge, strong project planning/management and effective communication skills.
Knowledge of global and regional regulatory environment and regulations.
Should be flexible and have experience and ability in managing regional teams both in resource limited settings (if applicable) and in a virtual environment.
Proven track record in successfully managing trials from start-up to database lock.
Experience with supervision of CROs/vendors is required.
Strong leadership skills.
Solid communication and computer skills required.
Proficient in speaking and writing English language. Excellent written and oral communication skills.
Strong experience in mentoring/coaching and providing training to local teams, such as CRO representatives, partners, and site staff.
Demonstrated ability to lead initiative/small teams.
Strong analytic skills and effectiveness in seeking solutions to problems.
Effective leadership skills and proven ability to foster team productivity and cohesiveness.
Specific therapeutic area experience may be required.
Must be willing to travel 50% of role.
Apply via :
jnjc.taleo.net
