Clinical Team Manager
Synteract
Madrid, Spain
hace 6 días

Who We Are

Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies.

With our mission of Bringing Clinical Trials to Life, we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations.

Our mission is to support the innovation and development of better therapies in healthcare. Position Overview The Clinical Team Manager (CTM) provides operational expertise and leadership in the planning, implementation and management of clinical trials through all periods of trial conduct.

The CTM is responsible for quality and on time’ delivery of clinical deliverables. All activities are conducted in accordance with the appropriate quality standards including ICH-GCP Guidelines, SOPs, applicable regulations, rules and guidance.

  • Please note, this role has the potential to be hired at the Senior Clinical Trials Manager level depending upon individual experience.
  • Specific tasks would include :
  • Serve as the primary clinical contact for both the Client and Synteract project team members
  • Serve as the primary point of contact for the clinical study team. Provide leadership throughout and maintain effective communication at all times
  • Work in collaboration with Synteract Project Management and functional project leads in the execution of clinical trials
  • Define and implement study-specific standards, goals and expectations for the clinical study team
  • Coordinate, facilitate, and, conduct training for clinical study teams as required. Address ongoing training needs throughout the study and ensure all trial-specific training is documented appropriately
  • Ensure completion of clinical activities within agreed timelines
  • Ensure adherence to the Clinical portion of the project budget; identify and consult with Project Management on clinical tasks that are out of scope
  • Oversee the quality and ensure compliance with project specific plans for all clinical deliverables; work with Project Management to identify and mitigate associated risks
  • Oversee site assignments and ensure clinical resources are continuously adequate
  • Participate in appropriate external study meetings, including both client and investigator meetings. Prepare and present as required
  • Coordinate and lead clinical meetings. Prepare agenda and minutes as required
  • Develop and maintain clinical study documents, templates, plans and manuals. These include, but are not limited to, the Clinical Monitoring Plan, Study Reference Manual and associated appendices
  • Develop, maintain and oversee trial specific tools to support the clinical operations team
  • Maintain oversight of site selection and activation activities. Ensure appropriate tracking throughout
  • Effectively interpret and report on clinical progress and associated metrics
  • Ensure applicable trial-related information is tracked and maintained in CTMS as required
  • Oversee the set-up and maintenance of the clinical portion of the trial master file (TMF)
  • Communicate with the Project manager and / or Line Manager as required, escalating issues of importance where appropriate
  • Track and review monitoring visit reports and ensure standards for monitoring and reporting are met; ensure appropriate and timely follow up on open action items
  • Maintain and review protocol deviation tracking, ensuring standards for reporting are met
  • Establish an effective and collaborative working relationship with external Vendors as appropriate, identifying both responsibilities and process
  • Provide input to clinical proposals, budgets and contracts
  • Support Business Development in preparing for and attending Bid Defense meetings
  • Contribute to the planning and conduct of feasibility studies
  • Conduct accompanied field assessment visits with CRAs as appropriate
  • Serve as Global CTM for international studies as necessary
  • Represent the clinical organization in the relevant Governance Committee(s) as necessary
  • Provide mentoring and / or oversight of less experienced CTMs and / or other members of the clinical department
  • Qualifications :

    Bachelor’s degree in a life science or related field of study OR equivalent combination of studies, nursing qualifications and / or work experience

    5 - 7 years relevant clinical research experience, including 3-5 years in a CTM or equivalent role

    Experience in aspects of clinical study management, including the review of visit reports and the development of study-related documents

  • In-depth working knowledge of current ICH-GCP guidelines and applicable regulations
  • Thorough knowledge of clinical research process
  • Strong communication skills including effective verbal, written and presentation skills; English + local language, if relevant
  • Demonstrated ability to lead, mentor and provide clinical guidance to team members
  • Intermediate proficiency in Microsoft Word, Excel, Outlook, Internet Explorer and PowerPoint
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