Clinical Affairs Manager

Summary

Join our team as a Clinical Affairs Manager and oversee the planning, execution, and management of clinical studies and trials. Ensure compliance with regulations and company policies while collaborating with cross-functional teams. Lead and mentor a team of clinical research professionals, manage clinical trial budgets, and monitor study progress. Contribute to clinical strategy and process improvement, ensuring timely and successful completion of clinical studies. This role requires strong leadership, communication, and project management skills, along with extensive experience in clinical research and regulatory compliance. The position offers a flexible work environment with potential for remote work.

Requirements

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field (required)
• Minimum of 5 years of experience in clinical research or clinical operations, with at least 2 years in a managerial or leadership role
• Experience in managing clinical trials from Phase I-IV, including working with CROs, vendors, and cross-functional teams
• Strong knowledge of GCP, FDA regulations, ICH guidelines, and other relevant regulatory standards
• Proven ability to manage multiple clinical trials simultaneously, ensuring adherence to timelines and budgets
• Excellent project management, organizational, and problem-solving skills
• Strong leadership and team management skills, with experience in mentoring and developing junior staff
• Excellent communication skills, both written and verbal, with the ability to present to senior leadership and external stakeholders
• Proficiency in clinical trial management systems (CTMS) and Microsoft Office Suite (Excel, Word, PowerPoint)
• Excellent written and oral communication skills

Responsibilities

• Oversee the management and coordination of clinical trials, including planning, budgeting, scheduling, and resource allocation
• Ensure clinical trials are conducted in compliance with Good Clinical Practice (GCP), regulatory requirements, and company standards
• Monitor study progress, identify potential risks, and resolve issues to ensure timely and successful completion of clinical studies
• Develop and review clinical study protocols, informed consent forms, and other study documents
• Ensure the appropriate selection of sites, vendors, and clinical investigators
• Lead, mentor, and supervise a team of clinical research professionals, which may include Clinical Research Associates (CRAs) and Clinical Trial Coordinators
• Act as the primary point of contact for internal and external stakeholders regarding clinical trial updates and issues
• Collaborate with other departments (e.g., regulatory affairs, quality assurance, and medical affairs) to ensure the clinical development program is aligned with organizational goals
• Ensure proper monitoring of clinical trial activities at investigational sites, including site initiation, patient recruitment, data collection, and adverse event reporting
• Conduct site visits, when necessary, to ensure compliance with study protocols and regulatory requirements
• Review data from clinical studies for accuracy and completeness, and work with data management teams to resolve discrepancies
• Ensure that clinical trials comply with all local, state, and international regulatory requirements, including FDA, EMA, and ICH-GCP standards
• Prepare and review regulatory submissions, as appropriate, in collaboration with the regulatory affairs team
• Assist in the preparation of Clinical Study Reports (CSRs), Investigator’s Brochures (IB), and other key documents for regulatory and clinical submissions
• Develop and manage clinical trial budgets, tracking expenditures to ensure projects remain within financial constraints
• Evaluate and select external vendors (e.g., CROs, laboratories, and diagnostic companies) as needed, ensuring they meet contractual and quality expectations
• Contribute to the development and refinement of clinical trial processes and standard operating procedures (SOPs)
• Participate in the development of clinical strategy and the design of new clinical programs
• Identify opportunities for improving clinical operations and efficiency, with a focus on quality, timeline, and cost optimization

Preferred Qualifications

Advanced degree (e.g., MSc, MBA, or MD) preferred

Benefits

A flexible work environment is possible, and may have the ability to work remotely, depending upon location