Study Start Up Leader (Clinical Trials) - Home-based
Parexel International Corporation, Billerica, MA, United States
Do you want to make an impact in your next role? Parexel is looking for changemakers who are driven by curiosity, passion, and optimism. Come join us in keeping the Patient at the Heart of Everything We do.
Parexel has new opportunities for home-based Study Start Up Leaders to join our global team. **Global experience is required.
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.
The Senior Study Start-Up Leader, is accountable as noted above including:
* Acting as study-level program lead, such as managing multiple protocol delivery for a Sponsor or asset development.
* Acting as an Enterprise or Biotech level lead and provide expert level knowledge on agreed partnership process.
* Additional responsibilities may include:
Study Start-Up Leader mentorship
Participation in training and support programs
Fulfilling subject matter expert or process improvement roles with Clinical Operations
Key Accountabilities:
* 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).
* Deliver and maintain client-focused reporting to measure performance and proactively identify issues for resolution.
* Ability to travel, as required.
Knowledge and experience:
* 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; 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
Education:
* Undergraduate degree preferably in a clinical or health related field required
* Advanced degree preferred
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
Full list of benefits available here:
At Parexel we embrace flexibility and understand that in today's fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, you're exposed to a world of experiences and open doors.
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