Single Sponsor Project Manager II (Inflammation)
Weekly presence at client office (Uxbridge), moving to Central London in May 27.
Therapy Area & Location
Inflammation. Based in the UK only. Some office presence at client office in Uxbridge, moving to Central London in May 27.
Project Leadership and Delivery
* Manage projects as Project Manager overseeing interdisciplinary clinical research programs, ensuring compliance with Good Clinical Practice (GCP), standard operating procedures (SOPs), and regulatory requirements.
* Act as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout per contractual agreements.
* Lead clinical team to ensure quality, timelines, and budget management.
* Accountable for the financial performance of assigned projects.
* Accountable for all project deliverables for assigned projects and/or project regions.
* Coordinate activities and deliverables of all project conduct partners and proactively identify and manage issues.
* Maintain project information on databases and systems, evaluate progress through timelines and analysis tools.
* Responsible for inspection readiness, including Trial Master Files.
* Provide oversight for development and implementation of project plans per Controlled Documents.
* Prepare, coordinate, and present project material at internal and external meetings.
* Direct activities of assigned Project Support staff; line manage and mentor project management and clinical staff; facilitate team building and communication.
* Prepare project management reports for clients and management.
* Implement resource strategies to achieve project goals.
* Develop contingency planning and risk mitigation strategies to ensure successful delivery of project goals.
Business Development
* Participate in bid defense meetings when presented as potential project manager/director.
* Develop strong relationships with current clients to generate new and/or add‑on business for the future.
* Maintain awareness of business unit’s and assigned projects’ therapeutic environment and drug development trends.
Management & Training
* May train and support new Project Managers; facilitate team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training.
* May be required to line manage other project management team members and clinical monitoring staff.
Qualifications
* Bachelor’s Degree (or equivalent) in life sciences, medicine, pharmacy, nursing, or related field, or equivalent combination of education and experience.
* Previous experience as a CTM/PM in a CRO or pharmaceutical company; strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process, and clinical monitoring procedures.
* Clinical research organization (CRO) and relevant therapeutic experience preferred.
* Strong ability to manage time and work independently.
* Experience managing multiple countries on a global level.
* Excellent communication, presentation, and interpersonal skills, both written and spoken.
* Flexibility and ability to mentor and manage new staff and handle multiple tasks to meet deadlines, delivering high‑quality work in a dynamic environment.
* Ability to travel as necessary (approximately 25%).
Legal & Equal Opportunity Statement
The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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