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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing site activation and regulatory activities for clinical trials, with a strong focus on compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Proven ability to lead multi-regional projects, mentor teams, and maintain effective relationships with stakeholders while ensuring quality and timely delivery.
Highest-signal resume keywords
Site Activation ManagementRegulatory Strategy DevelopmentGood Clinical Practice (GCP)Technical Writing SkillsProject Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory ComplianceClinical Trial ManagementDrug Development ProcessBudget PlanningNegotiation SkillsTechnical DocumentationData Management SystemsProject PlanningQuality ManagementRegulatory Intelligence
Soft Skills
Interpersonal SkillsTeam CollaborationLeadership SkillsPresentation SkillsOrganizational Skills
Tools & Technologies
CTMSDatabasesTracking Tools
Industry Keywords
Clinical EnvironmentInternational RoleStudy MaintenanceBid Defense ActivitiesRegulatory Guidelines
About the role
Key responsibilities & impact- Direct and manage delivery of site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs
- Oversee site activation, including pre-award and bid defense activities, and maintenance for assigned projects according to the site activation strategy and timelines
- Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan
- Resolve project-related issues and ensure collaboration across Regulatory & Site Activation, regions, and countries
- Create and/or review technical and administrative documentation supporting business development, study initiation, and maintenance
- Provide specialist regulatory and technical scientific support for business development, clinical trial initiation, and maintenance
- Guide and oversee multi-regional and multi-protocol programs during start-up and maintenance as part of the study management team
- Determine regulatory strategy, expectations, and submission parameters, including necessary authorizations
- Identify regulatory complexity and challenges and develop practical solutions supporting the bid process and site activation plan
- Assess the regulatory landscape and contribute to regulatory intelligence collection, interpretation, analysis, and dissemination
- Execute operational strategy for maintaining clinical study approvals and authorizations, and review/negotiate contracts and essential documents
- Work with Quality Management to ensure quality standards throughout site activation or maintenance
- Mentor and coach colleagues
- Maintain internal systems, especially CTMS, databases, tracking tools, timelines, and project plans
- Develop long-standing relationships with preferred IQVIA customers
- Deliver presentations and training to clients, colleagues, and professional bodies
- Participate in monthly study budget planning and reviews
Requirements
What you’ll need- Bachelor's Degree in Life sciences or related field required
- 7 years’ relevant experience in a scientific or clinical environment, including demonstrable experience in an international role
- Equivalent combination of education, training and experience
- Strong negotiation and communication skills with ability to challenge
- Excellent interpersonal skills and strong team player
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
- Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process
- Demonstrated proficiency in using systems and technology to achieve work objectives
- Good regulatory and/or technical writing skills
- Strong knowledge and ability to apply Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and applicable regulatory guidelines
- Good leadership skills, with ability to motivate, coach and mentor
- Good organizational and planning skills
- Ability to exercise independent judgment and take calculated risks when making decisions
- Good presentation skills
- Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors
- Excellent understanding of study financial management
- Proven ability to work on multiple projects while balancing competing priorities
Benefits
Comp & perks- Incentive plans, bonuses, and/or other forms of compensation may be offered
- Health and welfare benefits may be offered