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Global Clinical Project Lead
2 weeks ago
About the Role:
We are seeking a skilled professional to oversee complex global studies, act as a trusted advisor to clients, and mentor project managers and cross-functional team members.
Key Responsibilities:
- Lead end-to-end delivery for complex/late-phase or multi-country trials; oversee multiple concurrent Global studies or an integrated program.
- Serve as senior client liaison, providing strategic delivery guidance, issue resolution, and governance reporting.
- Shape protocol operationalization, country and site strategy, and enrollment rescue plans; lead risk assessment and Quality by Design activities.
- Own project financials: accurate forecasting, margin protection, change order strategy, and variance root-cause analysis.
- Oversee vendor strategy and performance (central labs, Medical imaging, etc.); negotiate scopes with stakeholders as needed.
- Ensure inspection readiness at all times; lead audit responses and CAPA programs; partner closely with quality assurance.
- Guide cross-functional leaders (Clinical, DM, Stats, Safety, Medical Writing, Regulatory) to align on critical path and scenario plans.
- Coach/mentor CPMs, CTLs/CRAs; may provide line management for a small team depending on portfolio needs.
- Contribute to proposals, bid defenses, and operational strategy in partnership with key teams.
Required Skills and Qualifications:
- Bachelor's degree in Life Sciences, Pharmacy, or related field; PhD, advanced degree or certifications (PMP/PRINCE2, ACRP) are a plus.
- Minimum of 8-10 years of experience as a Project Manager delivering Phase IIV trials in a clinical research organization or sponsor setting.
- Proven track record of leading multi-center, regional or global trials with measurable success on timelines, quality, and budget.
- Advanced skills in trial management, clinical operations, protocol implementation, and stakeholder leadership.
- Line management experience and capability building/mentoring across teams.
- Strong commercial acumen: budget management, change orders, contract/SOW interpretation.
- Excellent communication, negotiation, and conflict resolution skills; adept at working in fast-paced, dynamic environments.
- Experience across multiple therapeutic areas (e.g., Oncology, Hepatology, metabolic, CNS).
- Experience with global regulatory/ethics landscapes (ICH-GCP, FDA/EMA/MHRA).
- Depth with operational analytics, enrollment modeling, and risk signal detection tools.
Benefits:
The ideal candidate will have a strong background in project management, clinical operations, and stakeholder leadership. They should be able to work independently and as part of a team, and possess excellent communication and problem-solving skills.
Others:
Please submit your application, including your resume and a cover letter, to us.