Job title: Senior Clinical Team Manager – Anywhere US
Job description: Sr. Clinical Team Manager – Anywhere, US
Who We Are
Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.
The Senior Clinical Team Manager (Sr. 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.
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
- Bachelor’s degree in a life science or related field of study OR equivalent combination of studies, nursing qualifications and/or work experience
- 7+ years relevant clinical research experience, including 3-5 years in a CTM or equivalent role
- Dermatology or Oncology study experience preferred
- Demonstrated significant experience in the clinical management of studies; 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
- Well developed organizational skills in a complex and fast-paced environment.
- Intermediate proficiency in Microsoft Word, Excel, Outlook, Internet Explorer and PowerPoint
This job excludes Colorado applicants.
If you’re passionate about bringing clinical trials to life, we encourage you to apply today! Please apply online stating your earliest start date/notice period and your desired salary.
Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Candidates must possess current and valid authorization to work in the country to which they are applying. The Company will not sponsor applicants [to this position] for work visas.
Job date: Sat, 13 Mar 2021 08:48:39 GMT
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