Senior Clinical Trial Leader
ProClinical is partnering with a leading management consulting firm to advertise a vacancy for a Senior Clinical Trial position. The organization, which prides itself on its leading presence as a global advisor of talent supply chain strategies and workforce solutions, is seeking for a driven and talented individual to join its team in a home-based/remote capacity. This is an exciting opportunity to work for an international company and bolster a career in the clinical field.
- Executing clinical studies in support of the Client's team and their overall Clinical Center of Excellence with a focus primarily on clinical cardiovascular studies.
- Fostering strong, productive relationships with colleagues within the organization.
- Serving as a member or leader of the study core team and potentially serving as the liaison with the operating company for projects under their responsibility.
- Executing small-medium-large regulated and non-regulated clinical projects, or large non-regulated clinical projects including, but not limited to budget tracking, tracking and supporting subject recruitment, monitoring, quality of deliverables, site support and study closure.
- Providing support to department wide training.
- Ensuring and overseeing Quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical projects.
- Leading several small/medium/large clinical studies (regulated and non-regulated) that may involve Clinical Research Associates (CRAs) and/or other clinical operations staff.
- Assisting with or leading the management of large regulated studies alongside and in support of colleague CPMs or Senior CPMs and may support CPMs and/or Senior CPMs within a large or complex clinical study.
- Identifying and ensuring strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical studies under his/her responsibilities.
- Managing all activities of assigned clinical studies within the Clinical R&D Operations group.
- Functioning as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
- Evaluating support requests for publications and to provide consolidated comments and support to the requests.
- Managing Resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.
- Tracking assigned projects budgets to ensure adherence to business plans.
- Supporting the implementation of new clinical systems/processes, and provide support for publications, as needed.
- Independently solving problems that arise during clinical study execution.
- Interfacing and collaborating with investigators, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel.
- Ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
- Providing quality feedback to the Directors and Managers on each resource assigned to clinical studies regarding performance within the context of the clinical studies
- Serving as the primary contact for clinical trial sites.
Skills and Requirements:
- A minimum of a Bachelor's Degree required: Life Science, Physical Science, Nursing, or Biological Science degree is preferred.
- 5+ years of experience required as CRO- or Sponsor-level CRA or Clinical Project Manager.
- 1+ years of Clinical Project Management experience.
- Cardiovascular clinical trial experience strongly preferred.
- Personnel management experience strongly preferred.
- Medical device experience is preferred.
- Knowledge of Good Clinical Practices is required.
- Understanding and application of regulations and standards applied in clinical areas is required.
- Advanced project management skills with the ability to handle multiple projects required.
- Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
- Demonstrable project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Mary Jacobs at +267-477-4800 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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