Clinical Trial Manager

Discipline: Biotechnology, Pharmaceutical
Job type: Permanent
Contact name: Harun Noorzai

Contact email:
Job ref: 13334
Published: 23 days ago
For one of our leading clients I'm looking for a Clinical Trial Manager with end to end project management experience. 

· Services rendered will adhere to applicable company SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
· Complies with relevant training requirements.
· Lead the Study Management Team including providing updates to all trial team members on deliverable status.
· Ensure availability of required reports to support real time tracking of trial status according to trial plan.
· Manage timely and accurate documentation and communication of trial progress.
· Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness.
· Act as primary contact for Country and Regional staff.
· Act as the primary contact person for the local teams within GCDO.
· Partner with the Global Trial Lead to execute and oversee central activities from planning, trial start up, through the life of trial to close-out.
· Ensure issue escalation and drive issue resolution.
· Work closely with Trial Team to ensure CAPAs are resolved timely. Act as CAPA owner or contributor, as appropriate.
· Contribute to data collection to support the site selection process.
· Participate in feasibility, providing recommendations as needed.
· Establish enrolment commitments and ensure actual enrolment meets projected commitments across the regions at the clinical trial level.
· Ensure the availability of robust recruitment/contingency plans are in place for each region.
· Ensure timely tracking and filing in appropriate systems, as required at central trial oversight level.
· Perform Annual Quality Review of files, as appropriate.
· Ensure archiving and retention of documents per set requirements.
· Establish country budgets and monitor actuals vs. forecast for Out of Pocket Expenses.
· Oversight of selected vendors and status of related deliverables.
· Review and approve assigned vendor invoices/spend.
· Monitor budgets and expenditures as expected per planned trial budget.
· Create and update trial-specific documents as required; including Monitoring Guidelines, Informed Consent Form, Investigational Medicinal product (IMP) related documentation, Blinding Plan, country and site feasibility related documents.
· Provide input into cross functional documents such as safety related documents, protocol deviations and issue escalation processes, External Service Provider Oversight Plan and the Filing and Archiving Plan.
· Provide central documents required for HA/EC/IRB submission.
· Ensures creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed.
· Responsible for the set-up, coordination, attendance participation of Investigator Meetings.
· Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit.
· Demonstrate deep knowledge of protocol and procedures and adequate therapeutic area knowledge.
· Ensure compliance with Health Authority regulations and guidelines and internal standard operating procedures and processes.
· Participate in preparation for, and conduct of, Health Authority inspections and internal audits.
· Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools.
· Coordinate data cleaning with some supervision towards a timely and successful database lock.
· Act as central expert for assigned protocol(s).
· Sufficient therapeutic knowledge to support defined CTM roles and responsibilities.
· Contribute to process improvement and training, as applicable.
· Lead and/or participate in special initiatives, task forces, as assigned.

   · BS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
    · 6 years clinical trial management experience in the pharmaceutical industry or CRO. Specific therapeutic area experience.
o Advanced: 8 years clinical trial management experience in the pharmaceutical industry or CRO. Specific therapeutic area experience.
· Strong working knowledge of ICH-GCP, local laws and regulations.
· Superior clinical research operational knowledge. Proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure.
· Demonstrated effective leadership to proactively drive the Study Management Team through key stages of trials, as well as delegation skills.
· Effective leadership skills and ability to manage multiple stakeholders.
· Proven ability to lead a team through formation stages, up to operating as a high performing team.
· Experience and ability in coordinating global or regional teams in a virtual environment. Proven ability to foster team productivity and cohesiveness.
· Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years.
· Proven experience in proactive planning, risk mitigating and gaining team consensus on updated plans during the project lifecycle.
· Strong project planning/management.
· Independent complex decision making.
· Solution oriented and proactive risk identification and mitigation.
· Strong IT skills, including knowledge of standard Microsoft applications, Trial Master File, Clinical Trial Management System, and willingness to learn new systems.
· Monitoring experience is recommended, or other relevant experience should be considered, such as data management or central monitoring.
· Travel.
· Proficient in speaking and writing local country language and English.
· Effective verbal and written communication skills leading to successful team collaboration
· Strong decision making. Solution oriented.
· Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available.
· Experience in developing presentations and presenting key information to stakeholders.
· Ability to understand and competently plan and have oversight of country and select vendor budgeting processes, i.e. Understand and be aware of country Out of Pockets (OOPs) and FTE cost drivers.

       •  ASAP

If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme?
For more information please contact Harun Noorzai on   +31 (0)20 20 44 502