Company
Healthcare
LocalStudyAssociateDirector-FSP
Neural analysis suggests this role is
optimal for Director candidates.
“Local Study Associate Director- FSP. Skills: Clinical trial delivery, Site management, Regulatory compliance. Lead Local Study Teams. Coordinate Local Study Teams”
What You'll Achieve.
Successful delivery of clinical trial commitments; Timely communication of progress; Full compliance with quality standards; Full compliance with governance standards
Industry & Context.
Problem-solving; Risk mitigation
Ability to travel nationally, Ability to travel internationally
What They're Looking For.
Must Have
3 years of experience in clinical development operations, Knowledge of ICH-GCP guidelines, Knowledge of clinical trial regulatory requirements, Ability to lead cross-functional teams, Manage complex clinical study operations, Experience in site management activities, Project management skills, Organizational skills, Multitasking skills, Attention to detail, Excellent communication skills, Excellent interpersonal skills, Problem-solving skills, Proficiency in English, Fluency in local language(s), Familiarity with CTMS, Familiarity with eTMF systems, Familiarity with clinical trial documentation processes, Bachelor’s degree in life sciences or related discipline, Equivalent relevant qualification, Ability to travel nationally and internationally, Ethical standards, Integrity, Commitment to compliance
Nice to Have
CRA experience, Senior CRA experience, Experience in related environments
What You'll Do.
Lead Local Study Teams
Coordinate Local Study Teams
Ensure delivery of clinical trial commitments
Oversee site management activities
Ensure adherence to ICH-GCP
Ensure adherence to sponsor procedures
Ensure adherence to regulatory requirements
Manage study execution in CTMS
Ensure accurate documentation
Ensure accurate reporting
Maintain inspection-ready trial files
Act as primary operational leader
Communicate progress to stakeholders
Communicate risks to stakeholders
Communicate issues to stakeholders
Coordinate monitoring activities
Oversee monitoring activities
Review monitoring reports
Develop risk management plans
Maintain risk management plans
Identify operational risks
Mitigate operational risks
Support regulatory submissions
Support ethics approvals
Support IRB approvals
Support study start-up activities
Manage study-related budgets
Manage study-related contracts
Contribute to patient recruitment strategies
Maintain engagement with investigators
Maintain engagement with site staff
Lead audit readiness activities
Lead inspection readiness activities
Ensure compliance with quality standards
Ensure compliance with governance standards
Participate in cross-functional collaboration
How You'll Work.
Team & Collaboration
Local Study Teams; Global study stakeholders; CRA teams; Regulatory affairs teams; Cross-functional teams; Medical teams; Operational teams
Communication Scope
Communication; Interpersonal skills
Process & Methodology
Project management, Organizational skills, Multitasking skills
Full Job Description
## Accountabilities Lead and coordinate Local Study Teams to ensure successful delivery of clinical trial commitments at country level, including timelines, quality standards, and regulatory compliance. Oversee end-to-end site management activities, including feasibility assessment, site selection, qualification, initiation, monitoring, and close-out. Ensure adherence to ICH-GCP guidelines, sponsor procedures, and applicable local and international regulatory requirements. Manage study execution in CTMS and ensure accurate documentation, reporting, and maintenance of inspection-ready trial files (eTMF). Act as the primary operational leader for assigned studies, ensuring timely communication of progress, risks, and issues to global study stakeholders. Coordinate and oversee monitoring activities, including review of reports and support for CRA teams through training, coaching, and co-monitoring visits. Develop and maintain risk management plans, proactively identifying and mitigating study-related operational risks. Support regulatory submissions, ethics/IRB approvals, and study start-up activities in collaboration with regulatory affairs teams. Manage study-related budgets, contracts, and site payments in accordance with local requirements and sponsor agreements. Contribute to patient recruitment strategies and maintain strong engagement with investigators and site staff. Lead audit and inspection readiness activities, ensuring full compliance with quality and governance standards. Participate in cross-functional collaboration with medical, regulatory, and operational teams to ensure study alignment and success. Requirements Minimum 3 years of experience in clinical development operations, including CRA, Senior CRA, or equivalent roles within clinical research or related environments. Strong knowledge of ICH-GCP guidelines and clinical trial regulatory requirements at both local and international levels. Proven ability to lead cross-functional teams and manage comp
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