Clinical Study Manager

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Lead and manage project activities for a clinical study management role within a pharmaceutical company.

• Collaborate closely with the Global Trial Study Leader to support operational delivery.

• Execute designated studies in alignment with ICH GCP, local regulations, SOPs, timelines, budgets, and quality standards.

• Plan and operationally carry out specific tasks within the assigned clinical trials.

• Work with functional leads to achieve milestones and fulfill project objectives.

• Supervise strategic partners, including the selection of CROs/vendors, budget and contract negotiations, and performance oversight.

• Review and approve essential monitoring documents and plans, as well as evaluate monitoring outputs, decisions, and actions.

• Conduct oversight monitoring visits when applicable.

• Review and endorse pertinent study plans.

• Organize and participate in study team meetings, reviewing agendas and minutes.

• Analyze protocol deviation outcomes and actions to identify trends across sites or studies.

• Monitor study-level issues, risks, and decisions while implementing mitigation strategies.

• Review and maintain trial operational data, including data from CTMS.

• Oversee and evaluate internal trial reports.

• Ensure that studies remain inspection-ready and assist with regulatory inspections.

• Prepare for agency inspections by ensuring document readiness, tracking, storyboard development, and related preparations.

• Support data review for database lock and CSR writing and review, including appendices.

• Collect, review, and organize study documents for the trial master file and regulatory filing.

⛳️ Requirements

• A minimum of 5 years of experience in the pharmaceutical industry and/or clinical research organization.

• At least 3 years of oversight experience in clinical study management.

• Significant experience in study management support roles, such as clinical trial assistant/associate or lead CRA.

• Experience in early phase clinical studies or Phase 2 and 3 studies.

• Familiarity with global/international studies or programs.

• Experience across multiple therapeutic areas is a plus.

• Proven ability to successfully manage projects within defined scope, time, and budget constraints.

• Experience in vendor selection and oversight processes.

• Strong leadership and organizational capabilities.

• Excellent communication and interpersonal skills.

• Knowledge of global regulatory and compliance standards for clinical research, including US CFR, EU CTD, and ICH GCP.

• Understanding of local country requirements may be necessary.

• Proficiency in project management tools and methodologies.

• PMP or PRINCE2 certification is a plus.

• Detail-oriented, proactive, and adaptable.

• Fluent in business English, both oral and written.

• Legal eligibility to work in the country where the position is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Learning and development opportunities through structured training and career pathways.

• Stability, career development, and a collaborative work environment.

• Minimal travel; occasional travel opportunities may arise to support key trial meetings.