Global Medical Affairs Research Grant & Study Manager

The GMA Research Grant & Study Manager is responsible for the operational management coordination and oversight of Medical Affairs-sponsored evidence generation activities across regions. This is a highly collaborative role that supports the generation of high-quality scientific evidence to advance patient care and inform medical strategy. Responsibilities include Investigator-Sponsored Studies (ISS) research grants Phase IV company-sponsored studies observational research registries real-world evidence initiatives and other post-authorization research programs.

The role also serves as the primary coordinator and administrator for the ISS and research grants process ensuring efficient governance review contracting tracking reporting and this position you will work closely with cross-functional teams and external partners to ensure studies are conducted in accordance with applicable regulations company policies quality standards and evidence generation objectives. The role may also support expanded access/compassionate use programs and reimbursement addition it collaborates with Clinical Development colleagues to support Phase III clinical development programs and facilitate alignment between development and post-approval evidence generation activities contributing to a seamless evidence generation strategy across the product lifecycle.

What you will do

• Serve as the operational lead for the Investigator-Sponsored Studies (ISS) and research grants process ensuring efficient administration and governance.

• Coordinate the end-to-end lifecycle of ISS and research grant activities from submission through study close-out.

• Manage study contracts milestones budgets payments reporting requirements and maintain accurate study documentation and tracking systems.

• Facilitate cross-functional collaboration with Medical Affairs Clinical Development Compliance Legal Finance and external stakeholders to support evidence generation activities.

• Coordinate the planning execution oversight and close-out of Medical Affairs-sponsored evidence generation programs including Phase IV studies observational research registries and real-world evidence initiatives.

• Monitor study timelines deliverables operational performance and ensure studies are conducted in compliance with GCP regulations ethical standards and company procedures.

• Support Phase III clinical development programs and drive alignment between development activities and post-approval evidence generation strategies.

• Support expanded access compassionate use and other special research programs ensuring appropriate coordination documentation and tracking.

• Oversee external vendors and CROs monitoring performance quality timelines and budget adherence while proactively identifying and mitigating operational risks.

• Contribute to process improvements SOP development inspection readiness and initiatives that enhance operational efficiency compliance and transparency across evidence generation programs.

Qualifications :

What you will bring to the role

• Bachelors degree in Life Sciences Nursing Pharmacy Public Health or a related scientific discipline (advanced degree preferred).

• Minimum 58 years of experience in Clinical Research Medical Affairs Clinical Operations Clinical Development or Evidence Generation.

• Experience managing clinical studies including investigator-sponsored studies (ISS) Phase III/IV observational or post-marketing research.

• Experience coordinating research grants and investigator-sponsored studies is highly preferred.

• Strong knowledge of GCP ICH guidelines clinical research regulations and compliance requirements.

• Proven project management skills with the ability to manage multiple priorities and collaborate effectively with cross-functional stakeholders.

• Experience working with CROs investigators academic institutions and external research partners in a global environment.

• Strong analytical organizational communication and problem-solving skills with a high level of attention to detail.

• Proficiency with clinical trial management systems grants management systems electronic document management systems and Microsoft Office.

Ready to make a difference

Apply today and help us shape the future of eye health.

What we offer:

• Competitive Salary: A market aligned base salary starting from 78.863 GBP 108.436 GBP depending on experience and location.

Additional Information :

Grow your career at Santen
A career at Santen is an opportunity to make a difference. We aspire to contribute to the realization of Happiness with Vision by providing eye health products and services to patients consumers and medical professionals around the world. Guided by our CORE PRINCIPLE Tenki ni sanyo suru Santen is engaged in the global research & development manufacturing and sales and marketing of pharmaceutical products in ophthalmology.

We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes education and treatment. At Santen we believe in…