Global Site Start Up II

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

Parexel FSP has an exciting opportunity for a Global Site Start- Up Lead. As a Global Site Start-Up Lead II you will drive the global strategy and execution of clinical trial site activation partnering with cross-functional teams investigators and external partners to ensure studies launch efficiently compliantly and on schedule. This is an exciting opportunity for a clinical operations professional who thrives in a fast-paced environment enjoys solving complex challenges and is passionate about advancing drug development through strategic leadership operational excellence and data-driven decision-making

CORE JOB RESPONSIBILITIES:

Site Start-up Strategy

Develop the site start up strategy for each study outlining all dependencies impacting site activation and actively mitigating and escalating risks. Oversee the tracking and analysis of study metrics including risks and mitigation strategies and to evaluate CRO performance and implement corrective actions.

Advocate for optimized site selection strategies leveraging data-driven insights to guide cross-functional teams toward effective decision-making.

Lead the development assessment and alignment of site activation projections ensuring cross-functional and CRO collaboration to meet strategic objectives.

Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness.

Country Start-up

Partner with cross functional and CRO partners (where applicable) to develop a comprehensive global country start up strategy outlining all dependencies impacting country start up and actively mitigating and escalating risks cross functionally.

Monitor and maintain country intelligence data to support informed decision-making and develop accurate startup projections and strategic plans.

Support regulatory submissions as needed including activities such as providing required site documentation coordinating submissions to Central Institutional Review Boards (CIRBs) supporting sites with Local Institutional Review Board (LIRB) submissions and handling or supervising Clinical Research Organization (CRO) insurance requests etc.

Ensure timely country submission deliverables (ensure task completion; all roles clarity identification of critical path items effective communication pathway).

Site Start up Management

Lead and oversee all aspects of site start-up activities including fast-track site initiation site calls document collection and milestone tracking ensuring timely and efficient completion of processes.

Serve as the subject matter expert for essential site documents providing training guidance and support to teams and sites on regulatory requirements document management and TMF filing.

Oversee CRO site start up management or in house site facing regional SSU team where applicable

Lead the collection and analysis of site intelligence to support strategic site selection and site start-up.

Oversee the preparation and approval of site regulatory package ensuring compliance with country-specific requirements TMF standards and ICH-GCP guidelines while supporting inspection readiness and maintaining high-quality site documentation.

Team Interactions

Represent SSU on cross-functional teams providing updates escalating challenges and proposing mitigation strategies for site start-up issues.

Act as the escalation point for CRO and internal team to ensure timely SSU issue resolution

Process Improvement

Recommends and participates in cross functional and department process improvements.

May require up to 25% travel

Qualifications

• Demonstrated interpersonal & leadership skills
• Ability to understand and implement the operational strategic direction and guidance for respective clinical studies
• A data driven approach to planning executing and problem solving
• Effective communication skills via verbal written and presentation abilities
• Proactive and self-disciplined ability to meet deadlines effective use of time and prioritization
• Ability to influence and negotiate across key stakeholders
• Ability to build productive study teams collaborations
• Experience in the clinical drug development process with expertise in study start-up
• Demonstrated vendor management experience
• Technical proficiency in trial management systems (CTMS TMF) and MS applications including (but not limited to) Project PowerPoint Word Excel
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Effective project management skills cross-functional team interaction and organizational skills
• 4-6 years of experience

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Employment Type : Full-Time
Experience: years
Vacancy: 1