[Hiring] Global Project Manager @Clinilabs

Role Description

The Global Project Manager (GPM) oversees, leads, and coordinates the cross-functional operational aspects of ongoing global and multi-regional clinical projects to ensure that the clients’ goals of time, cost, and quality are met from protocol concept to final clinical study report. This role focuses specifically on Central Nervous System and serves as the primary operational contact with the client.

• Preparation and implementation of a global project plan, including the Integrated Quality Management Plan (IQMP) and Risk Management Plan.
• Ensure that site facilities and staff are adequate for clinical trials conducted at a global level.
• Review and provide input to clinical trial protocols and partner with the Clinical Manager.
• Review, approve, and implement strategies, policies, and standard operating procedures.
• Attend investigator meetings, governance committees, and other meetings related to clinical research activities.
• Develop, support, and comply with the annual budget, including billability levels, revenue, and expense targets.
• CNS Scale Management: Ensure robust quality control and standardization of specific CNS rating scales through proactive rater training and monitoring.
• Development of proposals in response to RFPs from pharmaceutical and biotech companies.
• Serve as primary operational contact with the sponsor regarding overall study conduct, timelines, quality, risks, financial performance, and budget.
• Responsible for allocation of resources to the study, including outsourcing and vendor identification.
• Maintain high-level oversight of global feasibility, regulatory submissions, and country/site activation.
• Receive, aggregate, and evaluate start-up metrics and site greenlight status updates.
• Provide strategic leadership and oversight to the Clinical Manager to ensure effective execution of monitoring plans.
• Collaborate with the Clinical Manager to review high-level monitoring trends and non-compliance issues.
• Development of project documentation per project scope of work.
• Responsible for tracking, managing, and reporting on the budget allocated to the project.
• Oversee site selection, initiation, and start-up activities.
• Oversee interim study conduct, including tracking subject recruitment and enrollment.
• Identify areas in which resources or progress are not consistent with the project plan.
• Communicate up-to-date information regarding overall study progress and key milestones.
• Responsible for study close-out, coordination of data query resolution, and database lock.
• Oversight of storage of documents in accordance with standard procedures.
• Other duties as assigned.

Qualifications

• Bachelor’s degree (Master’s preferred) in Life Sciences, Pharmacy, Nursing, or related scientific field.
• Approximately 5 to 7 years of direct clinical research project management experience.
• Project management experience with a proven track record of managing complex, multi-region, global clinical trials.
• Strong CNS Therapeutic Expertise with extensive operational experience leading CNS trials.
• Strong understanding of CNS endpoints and strategies to mitigate the placebo effect.
• Demonstrated knowledge of the overall drug development process.
• Proficiency with ICH/GCP guidelines, FDA, EMA, local regulations, and project management tools.
• Excellent verbal and written communication skills.
• Strong organizational, time-management, customer service, and interpersonal skills.

Requirements

• At least 5 to 7 years of experience in clinical research project management.
• Experience managing projects of various complexity within a CRO or Pharmaceutical environment.
• Proven track record of managing complex, multi-region, global clinical trials.
• Operational experience leading CNS trials in various therapeutic areas.
• Proficiency with ICH/GCP guidelines and regulatory requirements.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health and wellness benefits.
• Opportunities for professional development and career advancement.
• Flexible working arrangements.