Job Description

The Site Activation Partner is a senior clinical trial start-up specialist responsible for leading and executing site activation activities from study start-up through study conduct. The role ensures timely, high-quality, and compliant delivery in line with study requirements, country regulations, Good Clinical Practice (GCP), and Pfizer standards.

The Site Activation Partner serves as a key operational partner responsible for or supporting ethics and regulatory submissions activities, investigator site support, essential document management, and maintenance of study documentation throughout the clinical trial lifecycle

Depending on business needs and candidate experience, the role may support complex studies, act as Site Activation Point of Contact, provide multi-country coverage, mentor colleagues, and contribute as a subject matter expert for selected systems, processes, or initiatives.

Key Responsibilities

· Lead or support central and/or local ethics, IRB, regulatory, and other governing body submissions, including initial submissions, amendments, notifications, re-approvals, and ongoing maintenance activities.

· Coordinate the collection, review, validation, and submission of essential documents, including Investigator Initiation Package components, to support timely site activation and study conduct.

· Partner with investigator sites, study teams, regulatory stakeholders, preferred CROs, and local country teams to resolve submission queries, address issues, and escalate risks as appropriate.

· Maintain accurate updates in clinical trial systems and provide clear country/site-level status updates on timelines, issues, delays, approvals, and deliverables.

· Ensure timely filing and quality oversight of required documentation in the electronic Trial Master File (eTMF), supporting accuracy, completeness, and inspection readiness.

· Support investigator sites and study teams during audits, inspections, and quality reviews, including coordination of responses and documentation when required.

· Contribute to continuous improvement by applying quality principles, supporting process optimization, and participating in local, regional, or global initiatives as assigned.

· For more experienced candidates, mentor colleagues, support multi-country coverage, manage complex studies/sites, and act as SME for selected systems, processes, or initiatives.

Basic Qualifications

· BS/BSc/MS/MSc degree in a scientific or healthcare-related area, or equivalent combination of education, training, and relevant clinical research experience.

· Typically 4+ years of relevant experience in the pharmaceutical industry, CRO, clinical operations, site activation, regulatory, ethics/IRB submissions, or a closely related role.

· Experience interacting with regulatory agencies, Ethics Committees, IRBs, investigator sites, or equivalent governing bodies.

· Demonstrated deep knowledge of clinical trial methodology, ICH/GCP, applicable regulations, and country-specific requirements.

· Demonstrated ability to work in a matrixed, global environment and collaborate effectively with internal and external stakeholders.

· Strong written and verbal communication skills in English and the local language; multilingual capability is an asset.

· Good to excellent technical capability and ability to learn and use multiple clinical trial systems and collaboration tools.

· Ability to Independently use and learn new systems, and to deliver training sessions to Site activation partner team

Preferred Qualifications

· Experience supporting more than one country, complex studies, or high-volume site activation portfolios.

· Experience leading or actively contributing to cross-functional teams, task forces, or local/global initiatives.

· Strong prioritization, organization, and problem-solving skills, with the ability to work under pressure and meet deadlines.

· Quality-focused mindset, attention to detail, and commitment to right-first-time delivery.

· Ability to work independently, collaborate as part of a team, and influence stakeholders in a matrix environment.

Work Schedule / Travel

Flexibility may be required to support global collaboration and occasional off-hours meetings, where applicable. Travel requirements, if any, will be determined by business needs.

Leveling and Compensation

Candidates will be evaluated and hired at the level that best aligns with their education, experience, technical expertise, leadership capabilities, and business needs. Compensation and job level will be determined based on the selected candidate’s qualifications, demonstrated competencies, and relevant clinical research experience.

Work Location Assignment: Remote

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