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Site Activation Manager with Global Expertise
hace 1 semana
At Syneos Health, Inc., we are looking for a highly experienced and skilled Sr. Site Activation Manager to join our team.
Sr Site Activation Manager with global/regional experience sponsor dedicated Home Based Mexico, Brazil, Argentina, Peru, Colombia or Chile- We collaborate closely with major functional areas including Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management and Medical Writing.
- The ideal candidate will have a deep understanding of clinical trial start-up processes, project management experience in a fast-paced environment, strong organizational skills, excellent communication, presentation and interpersonal skills, quality-driven approach, and the ability to provide quality feedback and guidance to peers.
- The selected candidate will be responsible for ensuring all project deliverables meet internal and customer expectations, providing accurate projections, reports, and updates, and ongoing risk identification, mitigation, and management.
- They will develop and maintain relationships with customers in alignment with assigned projects, ensure individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed.
As a key member of our team, you will assume accountability on start-up deliverables, oversee site identification and selection, regulatory activities, clinical trial agreements, investigator budgets, Essential Document collection, and overall SSU timelines.
Key responsibilities include:
- Collaborating with cross-functional teams to identify and evaluate fundamental issues pertaining to Site Start-Up and successful patient enrollment.
- Ensuring all project deliverables meet internal and customer expectations as per contracted deliverables.
- Developing and maintaining integrated site start-up timelines and reports weekly progress, including plans to address potential timing risks/gaps.
- Reviewing project SSU budget with functional leads, PM, and SSU Business Unit Controller against project milestones and budget to ensure project profitability.
- Performing Regulatory Impact Assessment on core amendment submission documents and communicating any risk mitigation to Sponsor/Project teams.
- Overseeing collation, quality review, and submission of country-specific applications.
Qualifications
We are seeking candidates with a Bachelor's Degree, Higher Degree Preferred. Minimum 6 years CRO industry experience and/or a minimum 5 years' experience working in a SSU, or clinical trial environment or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job.
