Study Start-Up Leader

4 weeks ago

Nagpur, Maharashtra, India Parexel Full time

Unlock Your Potential as a Study Start-Up Leader

Parexel is seeking a highly skilled Study Start-Up Leader to join our global team. As a Study Start-Up Leader, you will be responsible for the execution of the study start-up strategy and planning, including 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:

  • Manage the study start-up process, through development of a site activation strategy and to oversee 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).

Requirements:

  • 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.

Parexel Benefits:

  • 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

At Parexel, we value our employees and offer a range of benefits to support their well-being and career development. We are committed to creating a diverse and inclusive work environment that fosters collaboration and innovation.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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