Clinical Team Manager/Sr. (CTM) - FSP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Clinical Trial Manager - Make an Impact at the Forefront of Innovation

The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs.
 

Summary

Take responsibility for coordinating the clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned Phase I clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality, timely delivery and within budget, in order to assist in the delivery of Clinical Development objectives and achieve clinical excellence. Coordinate the achievement of assigned clinical study deliverables within a matrix organization under the leadership of the Clinical Project Managers (CPM). Be a client representative at site and build relationship with our investigators.

Main Responsibilities/ Job Expectations

• Ensure clinical activities coordination & oversight
• Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set-up (DM, reg, CMC, etc); ensure feasibility report are exhaustive,  Review site feasibility reports as per oversight plan , support the CPM in site selection, verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation, as per the oversight plan.
• Support and ensure that all specific Client/CRO EDC system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardizing the start of a trial. Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate  in  the  organization  and  preparation  of  the  monitor  and  investigator  meetings  in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate) Assist the CPM/ study team in the evaluation of detailed timelines and establishment of clinical studies milestones for assigned projects, ensuring that they are performed to the most rigorous standards of quality and timely delivery.
• Prepare and/or assist in the production of all documents necessary to oversee the clinical activity implementation, monitoring and reporting in a professional, high quality and timely manner (such as monitoring oversight plan and clin
• Customize site Key Risk/Performance Indicator template and follow these KRIs/KPIs at frequency agreed in the oversight plan
• Validate the final clinical study documents (such as study manual, monitoring plan, prepared by the Clinical CRO.
• Review all/a sample of site visit reports as per the Oversight Monitoring Plan, ensuring timely and appropriate follow up of issues raised by monitors (Corporate & affiliates and/or CROs as appropriate).
• If applicable, provide support and guidance to Internal CRAs (Client Corporate & Affiliates with provision of some supervision in specific cases).
• Coordinate and manage the CRO relationship, assisting CRO CRAs/CTLs when and where necessary. Collaboration with the CPM in the RFP process and participation to BID defense meeting
• If applicable to set up regular meeting with MSL (Medical Science Liaison) at LMA (Local Medical Affairs) who can support Clinical Operations at various steps (site qualification, site recruit
• Contribute to the efficient operation of the TA Group and to transversal project cross- TAs and other departments within client (e.g. systems implementation, change management initiatives, continuous improvement initiatives
• Ensure the monitoring oversight of different activities entrusted
• Co-monitor clinical studies according to the oversight plan, ensuring adequate contact with investigator sites, identifying and solving issues in study progress, verifying data in-house or by conducting co- monitoring visits, in collaboration with other study team