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.