- Manage the study start-up process, developing a site activation strategy and overseeing start-up delivery and governance.
- Coordinate, develop, and articulate the critical path planning, and implement as part of the Site Initiation Scheduling, System Set-up, EDL Management, EC & RA/MoH Strategy, ICF Customization, Risk Mitigations, Monitoring Plan, Site Activation Requirements & Relevant Tools.
- Collaborate and communicate within the Global study team matrix to provide study start-up strategy, input to milestone development, and alignment of operational targets to ensure timely delivery of study start-up activities.
- Participate in client meetings with respect to study start-up, including endorsement of the SSU Operational Targets & mitigation of delivery risks, establishing client expectations for delivery, communication, reporting, and metrics.
- Partner closely with both Functional Leaders and Local Site Managers to proactively identify study start-up related issues.
- Develop and execute corrective actions to mitigate risks to activation timelines.
- Ensure that relevant systems are maintained and up to date to analyze study start-up progress metrics against targets/timelines (at a project/country/site level).
- Proven client-facing relevant experience in healthcare, clinical research, project management, or contract research organization.
- Global experience in SSU is preferred but not required.
- 2+ years' experience working as a Study Start-Up Leader (SSUL) within a CRO, Biotech, or Pharma preferred; additional years of experience required at the Senior level.
- Minimum 2+ years of experience in project scheduling, managing resources, budgets, and coordinating team activities.
- Must be detail-oriented; proficient in Windows environment and possess superior interpersonal skills and organizational skills.
- Competent in written and oral English.
- Undergraduate degree preferably in a clinical or health-related field required.
- Advanced degree preferred.
- Health, Vision & Dental Insurance.
- Tuition Reimbursement.
- Vacation/Holiday/Sick Time.
- Flexible Spending & Health Savings Accounts.
- Work/Life Balance.
- 401(k) with Company match.
- Pet Insurance.
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Global Study Start-Up Manager - Nagpur, India - Parexel
Description
About the Role:
The Study Start-Up Leader is a critical position within our organization, responsible for the execution of the study start-up strategy and planning. This includes the management and coordination of start-up activities such as alignment to country regulations, Core/Site document collection/approval, ICF customization/approval, EC and RA/MoH submissions, SIV scheduling and activation requirements.
Key Responsibilities:
Requirements:
Education:
Parexel Benefits:
