(Sr) Project Manager, Feasibility Site Activation
New
J
JobgetherClinical Research
IndiaFull-TimeSenior
Salary not disclosed
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Job Details
- Required Skills
- Project ManagementStakeholder management
Requirements
- Proven experience managing Study Start-Up (SSU) activities as a primary responsibility.
- Experience supporting global or multi-country clinical trials within a clinical research organization, pharmaceutical, or healthcare environment.
- Strong understanding of regulatory and ethics submission processes.
- Experience managing site contracts, budgets, and activation timelines.
- Demonstrated ability to manage competing priorities, project risks, dependencies, and critical milestones.
- Hands-on experience with clinical trial systems such as CTMS and eTMF.
- Strong knowledge of ICH-GCP guidelines and applicable clinical research regulations.
- Excellent stakeholder management skills.
- Ability to work collaboratively across global, cross-functional teams.
- Strong analytical, organizational, and problem-solving skills.
Responsibilities
- Develop and execute Study Start-Up strategies for global and multi-country clinical studies.
- Lead the creation and implementation of comprehensive Study Start-Up Plans covering regulatory submissions, ethics approvals, contracts, and site activation milestones.
- Manage end-to-end site activation activities from site identification through activation and investigational product release.
- Provide strategic input during bid defense and study kick-off meetings.
- Oversee regulatory and ethics submission activities to ensure timely approvals.
- Coordinate site contract and budget negotiations with sponsors, legal, finance, and site stakeholders.
- Identify operational risks and dependencies while implementing mitigation plans.
- Maintain inspection readiness and quality documentation via CTMS and eTMF.
- Monitor study metrics, budgets, and performance against agreed objectives.
- Drive process improvements and operational excellence initiatives.
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