Be the backbone of innovation and join a leading pharmaceutical company to help keep life-changing science moving forward!
Proclinical is seeking a Medical Affairs Associate for a contract role within the medical affairs field. In this role, you will coordinate and manage the Investigator Initiated Research (IIR) program across multiple countries, ensuring compliance with global and local policies. You will oversee ongoing studies, maintain inspection readiness, and collaborate with internal and external stakeholders to ensure successful study execution.
Responsibilities:
* Act as the primary point of contact for affiliates and business partners regarding externally sponsored research studies.
* Negotiate and finalize contracts and amendments while tracking trial compliance.
* Monitor and manage costs, timelines, scope, and risks for the IIR program using required tools and techniques.
* Forecast timelines and financial metrics by liaising with affiliates and investigators to obtain updated data.
* Maintain inspection-readiness through proper documentation and electronic file management.
* Track studies from protocol approval to close-out, including site close-out activities, final deliverables, and archiving.
* Ensure effective communication with investigators and relevant functions throughout the study lifecycle.
* Develop and implement escalation plans to address study milestones and adherence issues.
* Facilitate operational meetings with external investigators.
* Oversee clinical supply requests, feasibility, and forecasting.
* Ensure adherence to medical and quality procedures.
* Manage study deliverables, including final reports, publications, and regulatory submissions.
* Update and maintain IIR tools and portals for inspection readiness.
* Coordinate budget changes, agreements, and amendments as needed.
Key Skills and Requirements:
* Bachelor's degree in a scientific or health-related field or equivalent clinical research experience.
* Experience in contract creation and negotiation.
* Strong writing, editing, and communication skills.
* Proven ability to work with cross-functional and cross-country teams.
* Demonstrated problem-solving and project management skills.
* Excellent organizational and self-management abilities.
* Knowledge of clinical drug development processes, medical research regulations, and guidelines.
* Familiarity with medical terminology and regulatory requirements.
* Proficiency in project management tools such as CTMS and Excel.
* Experience in finance-related tasks, such as invoice processing and purchase order setup, is a plus.
If you are having difficulty in applying or if you have any questions, please contact Dean Fisher at d.fisher@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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