The Company
My client is one of the largest global medical technology companies who specialise in finding solutions and services to help advance clinical therapy for patients and clinical process for health care providers. Based throughout the United States, they are looking to acquire an exceptional Clinical Study Manager to join their team.
The Role
The Clinical Study Manager is responsible for clinical trial management and monitoring of multiple studies including the planning, implementation, oversight and completion of clinical trials conducted that are post market studies. The Clinical Study Manager will ensure that Investigator Sponsored Studies (ISS) and post market studies or research collaborations are initiated and executed as required. This role serves as the combined study manager and monitor of moderate to high complexity from study initiation, through study conduct and closeout in compliance with Good Clinical Practices, and all Global, National and Local Regulations as well as MA Governance of ISS studies. Collaborates with SA Clinical Project Lead to review business requests, and evaluate or develop early plans and concepts for optimal study execution.
About you
Responsibilities
- Develops and manages group of studies for an entire business unit or large development program; oversees/leads study-specific study management and monitoring activities
- Prepares, reviews or supplies as needed study-related or essential study start-up documents as they relate to the assigned clinical trials e.g., Clinical Protocols, Informed Consent forms, Investigator Brochures, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters) for the company’s sponsored post market studies.
- Ensures study supplies and product training is initiated and maintained as needed.
- Serves as study monitor over the study conduct and milestone progress.
- Addresses issues that may arise during execution of clinical studies.
- May manage relationships with site personnel and other study related vendors, including CRO’s.
- Defines, tracks and reports schedule attributes such as durations, interdependencies, milestones, budgets, critical path and other key deliverables for assigned studies.
- Adapts work package deliverables based on study scale and complexity.
- Proactively identifies and manages risks and issues (including a log, mitigations, and contingencies) to ensure cost effective timely delivery of the project including escalation if needed
- Plans and maintains high quality standards in order to meet compliance requirements.
- Leads or contributes to continuous improvement activities/initiatives.
- Ability to travel approximately 30% of the time, US and Internationally.
Requirements
- BS Degree in Medical Technology, Microbiology, Biology, Chemistry, Immunology or equivalent
- A minimum of 2+ years of Clinical Microbiology experience.
- Project management experience desirable using MS Project and/or recent proven success within product development core/extended team.
- Knowledge of clinical trial concepts and practices
- Strong client and vendor relationship management skills.
- Ability to work effectively, independently with multi-level teams, manage multiple projects and work in a fast paced and changing environment.
- Demonstrated and effective interpersonal, communications and negotiation skills for a wide variety of audiences.
- Ability to work effectively in a virtual environment.
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives