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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in clinical study management, including oversight of Phase 2 and 3 studies, vendor selection, and compliance with global regulatory standards. Proficient in project management methodologies and tools, ensuring successful project delivery within scope, time, and budget constraints.
Highest-signal resume keywords
Clinical Study ManagementRegulatory ComplianceProject Management ToolsVendor SelectionLeadership Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ManagementICH GCPUS CFREU CTDData ReviewBudget ManagementContract NegotiationMonitoring OutputsTrial Master File ManagementRisk Mitigation
Soft Skills
Communication SkillsInterpersonal SkillsOrganizational SkillsDetail-OrientedProactive
Tools & Technologies
CTMSProject Management Software
Certifications & Qualifications
PMPPRINCE2
Industry Keywords
Pharmaceutical IndustryClinical Research OrganizationGlobal StudiesTherapeutic AreasInspection Readiness
Tech Stack
Tools & technologiesPMP
About the role
Key responsibilities & impact- Lead and coordinate project activities for an FSP clinical study management role dedicated to one pharmaceutical company
- Support operational delivery in close collaboration with the Global Trial Study Leader
- Execute select studies in compliance with ICH GCP, local regulations, SOPs, schedule, budget, and quality standards
- Plan and operationally execute specific tasks within assigned clinical trials
- Coordinate with functional leads to deliver milestones and meet project objectives
- Oversee strategic partners, including CRO/vendor selection, budget and contract negotiation, and performance supervision
- Review and approve key monitoring documents and plans, and review monitoring outputs, decisions, and actions
- Conduct oversight monitoring visits, as applicable
- Review and endorse relevant study plans
- Manage and attend study team meetings and review agendas and minutes
- Review protocol deviation outcomes and actions to identify trends across sites or studies
- Monitor study-level issues, risks, and decisions and implement mitigation strategies
- Review and own trial operational data, including CTMS data
- Review and provide oversight of internal trial reports
- Ensure studies remain inspection ready and support regulatory inspections
- Prepare for agency inspections, including document readiness, tracking, storyboard development, and related preparations
- Support data review for database lock and CSR writing and review, including appendices
- Collect, review, and file study documents for the trial master file and regulatory filing
Requirements
What you’ll need- 5+ years’ experience in the pharmaceutical industry and/or clinical research organization
- 3+ years’ clinical study management oversight
- Significant study management support experience, such as clinical trial assistant/associate or lead CRA
- Experience in early phase clinical studies or Phase 2 and 3 studies
- Experience with global/international studies or programs
- Experience in more than one therapeutic area is advantageous
- Proven track record of successfully managing projects within scope, time, and budget constraints
- Experience in vendor selection and oversight
- Strong leadership and organizational skills
- Excellent communication and interpersonal skills
- Knowledge of global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH GCP
- Awareness of local country requirements may be required
- Proficiency in project management tools and methodologies
- PMP or PRINCE2 certification is advantageous
- Detail-oriented, proactive, and adaptable
- Fluent business English, oral and written
- Legal right to work in the country where the role is based
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
- Stability, career development and a collaborative environment
- Minimal travel; occasional travel opportunity to support a key trial meeting may arise