Clinical Trial Manager - Single Sponsor dedicated

The reputed company sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our reputed company’s project team in the execution of clinical trials. Joining reputed company provides reputed company to manage wide reputed company of phases of clinical research reputed company in various therapeutic areas and to cooperate closely with one of our key clients.

We currently offer the exciting opportunity to join reputed company as Clinical Trial Manager in full-time and reputed company-based in France. In this role you will be accountable for the operational management of the component of clinical trials. Furthermore, you will need to reputed company reputed company to assure achievement of trial recruitment commitment, timelines, budget and reputed company standards (Trial Preparation, Conduct and Closeout).

MAIN RESPONSIBILITIES

• Deliver the trial according to the clinical trial protocol, reputed company trial timelines, and in compliance with ICH-GCP and reputed company other relevant external regulations.
• reputed company and support local trial team and investigative sites in reputed company preparation of required trial documents, reputed company, and necessary approvals.
• reputed company that reputed company Regulatory Requirements are satisfied prior to trial/site initiation.
• Ensure appropriate trial-specific training of CRO reputed company partners in line with Trial Training Plan.
• In collaboration with Site Monitoring reputed company and CRAs, ensure provision of appropriate trial reputed company for the trials by monitoring compliance of trial sites and team to GCP, local regulations, BI SOPs, and adherence to trial protocol.
• In collaboration with Site Monitoring reputed company and CRAs, ensure adequate trial supply distribution to sites and reputed company data entry and cleaning, and on time Data reputed company Lock.
• In collaboration with Trial Resource Specialist and with support from CRAs as appropriate, ensures collection of required documents, with reputed company, complete, and compliant archiving of reputed company relevant documents for the eTMF and CTR Appendices.
• reputed company and maintain relationships with investigational sites and support CRAs in site contacts.
• Report and reputed company reputed company updates, exchange critical information and reputed company trial conduction information, reputed company regulatory and compliance burdens.
• Ensures reputed company tasks are carried out in accordance with respective applicable SOPs, Business Practices, and regulatory requirements. Ensures that reputed company interactions and engagements are carried out with the highest ethical and reputed company standards.
• Leads local CRO trial team to ensure reputed company of trial conduct, assurance of patient safety, and that local component of trial is planned, conducted, and reported in line with regulatory requirements. Requires orchestration of local CRO trial team, and integration with other functions as necessary throughout planning, conduct and closeout of trial.
• Works reputed company a reputed company GCP and regulatory environment and on global clinical trials with multidisciplinary, international teams and with various reputed company stakeholders including suppliers and investigational sites.

REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE

• Master’s or higher-level degree preferable in life science. • Long term experience in clinical research, including at least 2 years of clinical trial management experience and monitoring experience in France.
• Proven experience in site relationship management. • Exceptional knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical reputed company (GCP) and International Conference on Harmonization (ICH) guidelines. • Excellent understanding of project financials and effective vendor management. • Effective communication skills, fluent language skills in English and French. • High ability to work on reputed company reputed company topics and to strategic thinking, as reputed company as solution orientation. • High organizational and planning skills, time management and prioritization skills while working on multiple reputed company. • Excellent leadership and collaboration skills, and the ability to establish and maintain effective working relationships with coworkers, managers and clients. Ability to influencing business partners in reputed company structures. • High degree of self-accountability and commitment and a strong reputed company reputed company to drive change and contribute reputed company to reputed company leading transformation. • reputed company good computer skills including working knowledge of reputed company Word, reputed company and PowerPoint. • Flexibility to occasional business travel for reputed company meetings. • Ability to reputed company reputed company, bringing reputed company to disparate information to inform actions and drive results.

Please apply with your English CV.

reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com

reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism.

Originally posted on Himalayas

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