Study Manager – Infectious Disease

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

📋 Description

• Oversee interdisciplinary clinical research studies in the capacity of a project manager.

• Ensure adherence to Good Clinical Practice (GCP), relevant Standard Operating Procedures (SOPs), and regulatory standards.

• Serve as the primary point of contact between the Company and the Client.

• Guarantee timely initiation, execution, and completion of studies.

• Lead project teams to ensure adherence to quality standards, timelines, and budget constraints.

• Manage the financial performance of projects.

• Coordinate study conduct partners and address any arising issues.

• Supervise project deliverables and ensure the quality and completeness of the Trial Master File (TMF).

• Maintain study-related information in databases and systems.

• Ensure inspection readiness and develop project plans.

• Organize, coordinate, and lead internal and external meetings.

• Prepare project management reports for clients and upper management.

• Create contingency plans and strategies for risk mitigation.

• Cultivate client relationships to foster future business opportunities.

• Participate in bid defense meetings as a prospective project manager.

• May oversee and manage project management team members and clinical monitoring staff.

⛳️ Requirements

• Bachelor’s Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing, or a relevant combination of education and experience.

• Previous experience in a Clinical Research Organization (CRO) and relevant therapeutic areas is preferred.

• Comprehensive understanding of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.

• Exceptional organizational skills.

• Strong ability to manage time effectively and work independently.

• Expertise in the relevant therapeutic area.

• Willingness to adopt new technologies.

• Outstanding communication, presentation, and interpersonal skills, both verbal and written.

• Ability to travel as needed (approximately 25%).

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and involved line management.

• Technical and therapeutic area training provided.

• Peer recognition along with a comprehensive total rewards program.

• Medical, Dental, and Vision health benefits.

• Company-matched 401k plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Potential to earn commissions or bonuses based on individual and company performance.

• Flexible paid time off (PTO) policy.

• Sick leave provided.

• Company car or car allowance may be included.