- Contribute to critical post-approval studies in a leading global pharma.|Work with diverse stakeholders in a dynamic industry, fostering valuable connect
About Our Client
Our client is a global life sciences company, dedicated to making a positive impact on people's lives and the planet. With a rich history spanning over several decades, our client has established itself as a leading force in the fields of healthcare and agriculture. Through innovative solutions and a strong commitment to sustainability, our client continues to shape the future of medicine, nutrition, and high-quality agricultural products.
Job Description
- Oversee the implementation and management of post-approval studies, encompassing Non-Interventional Study (NIS) and Investigator-Initiated Research (IIR) initiatives, spanning various therapeutic areas. Ensure stringent adherence to medical governance, regulatory compliance, and high-quality data delivery.
- Facilitate the facilitation of new drug applications by orchestrating the country assessment report, a pivotal regulatory prerequisite for registration studies.
- Spearhead site management activities and protocols for NIS, ensuring the optimal performance, adherence to quality standards, efficiency, and efficacy of the trial sites.
- Supervise the internal Site Management budget, with a focus on overseeing external clinical grants on an annual basis. Such grants encompass all costs associated with relevant NIS and IIR clinical trials, including investigator payments and study supplies.
- Guarantee the provision of adequate and efficient resources for each clinical trial, aligning resources with trial needs and objectives.
- Foster close collaboration with medical advisors and Medical Science Liaisons (MSLs) within pertinent Therapeutic Areas (TAs) to ensure the success of ongoing studies.
- Manage contracts, vendor relationships, budgetary allocations, and administrative coordination of patient support programs, in consultation with the responsible Medical Advisor for the program.
- Assume responsibility for the management of the post-approval study team, ensuring their competency training and professional development.
- Ensure the streamlined execution of NIS & IIR, adhering to internal benchmarks and meeting local legal and regulatory requirements.
- Foster the development of a robust clinical investigator network in the region to support efficient clinical trial execution and contribute to the overall business strategy.
The Successful Applicant
- Possession of a Bachelor's degree (or equivalent) in a science or healthcare-related field.
- Minimum of 5 years hands-on experience in clinical trials or clinical operations, with a solid grasp of ICH-GCP guidelines and pertinent legal, compliance, and regulatory mandates.
- Demonstrated experience in leading teams, showcasing strong leadership, motivational, and collaborative skills.
- Proficiency in administrative, financial, and technical competencies, along with excellent verbal and written communication abilities in English, both internally and externally.
- Ability to think strategically, with a keen eye for the bigger picture and a focus on fulfilling broader business objectives.
- Exhibit innovation and creative problem-solving capabilities, while maintaining a results-driven approach.
- Possess a strong business acumen and demonstrate genuine interest in business dynamics and operations.
What's On Offer
Join an organization committed to innovation and professional development, driving transformative change in the global life sciences sector.
Contact: Jenny I Wang
Quote job ref: JN-102023-6212586
