Study Start Up Director

6 days ago


Billerica, Massachusetts, United States Parexel International Corporation Full time

Parexel International Corporation is seeking an experienced Study Start Up Leader to join our global team. This role offers a unique opportunity to make a significant impact in the healthcare industry.

Job Description

The Study Start Up Leader is accountable 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 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.
Requirements

To be successful in this role, you will need:

  • Proven client-facing relevant experience in healthcare, clinical research, project management, or contract research organization.
  • Global experience in SSU is required.
  • 2+ years' experience working as a Study Start-Up Leader (SSUL) within a CRO, Biotech, or Pharma preferred.
  • 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.
What We Offer

Parexel International Corporation offers a competitive salary of $120,000 - $160,000 per year, plus benefits including health, vision, and dental insurance, tuition reimbursement, vacation/holiday/sick time, flexible spending and health savings accounts, work/life balance, and 401(k) with company match.



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