Manager Clinical Affairs

Role Description

Qity Clinical, a specialized service provider offering expert Clinical Affairs consulting to life science companies, is looking for a highly skilled and scientifically driven Clinical Affairs and Clinical Program Manager to lead and manage clinical programs for our life sciences clients. This role requires a strategic leader with a strong scientific background, capable of overseeing all aspects of clinical affairs and program management, from planning and execution to managing vendor selection, regulatory submissions, and key opinion leaders (KOLs). As a Clinical Affairs Manager at Qity Clinical, you will play a crucial role in shaping our clients' clinical development strategies, ensuring scientific rigor and regulatory compliance.

Responsibilities

• Lead and manage clinical programs, from strategic planning and protocol development through to clinical study reports and regulatory submissions.
• Provide scientific and clinical expertise to support the design and execution of clinical trials, ensuring alignment with regulatory requirements and scientific objectives.
• Develop and manage clinical trial budgets
• Lead clinical vendor bidding, contract negotiation, and oversight of vendor performance.
• Identify, engage, and manage relationships with key opinion leaders (KOLs) to support clinical development activities and scientific initiatives.
• Oversee vendor selection and management, ensuring quality and adherence to project timelines and budgets.
• Develop and maintain essential study documents, including protocols, investigator brochures, clinical evaluation reports, and regulatory submissions.
• Oversee monitoring and analysis of clinical data, ensuring data integrity and adherence to GCP/ICH guidelines.
• Provide scientific input and support for regulatory interactions and submissions.
• Manage and coordinate activities of cross-functional teams, including clinical operations, data management, biostatistics, and regulatory affairs.
• Proactively identify and address potential risks to clinical programs.
• Support the preparation of scientific publications and presentations.
• Contribute to Qity Clinical's business development and expansion.

Qualifications

• Permission to work in Belgium, Europe.
• Bachelor’s or Master’s degree in a life sciences field.
• Extensive experience in clinical affairs and program management, with a strong scientific background and understanding of clinical development processes.
• Proven experience in managing clinical trial budgets, vendor bidding, and vendor oversight.
• Demonstrated ability to identify, engage, and manage relationships with key opinion leaders (KOLs).
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
• Strong analytical and problem-solving skills, with the ability to interpret and analyze complex scientific data.
• Experience with regulatory submissions and interactions with regulatory authorities.
• Strong leadership and team management skills, with the ability to motivate and inspire cross-functional teams.
• Excellent communication, interpersonal, and presentation skills.
• Strong problem-solving and decision-making abilities.
• Proficiency in clinical trial management systems such (CTMS), Trial Master File (TMF) and electronic data capture (EDC) systems.
• Strong computer skills.
• Ability to travel as required.
• The candidate will work primarily from the Qity Clinical office, but may also be allocated to client sites as needed.

Why Join Qity Clinical?

Qity Clinical offers a unique opportunity to lead and contribute to impactful clinical affairs consulting. As a starting company, we provide a dynamic and collaborative work environment where you can:

• Play a key role in building and shaping our clinical affairs capabilities.
• Work on a variety of clinical programs and clinical activities across different therapeutic areas.
• Contribute to the implementation of best practices and innovative approaches to clinical program management.
• Benefit from opportunities for career advancement and personal development.
• Contribute to the success of our clients' clinical development programs and ultimately improve patient lives.
• Work alongside a team with excellent team spirit, teamwork, and a human approach.
• Gain experience in a large array of clinical affairs matters due to the starting nature of the company.
• We offer a flexible Work From Home (WFH) policy.
• We prioritize creating an environment that fosters flexibility, growth, and personal development.