Overview
Senior Clinical Team Manager – PPD, a part of Thermo Fisher Scientific, invites you to re-imagine health-promotion protocols with a talented, energetic team. The Project Delivery team directs, coordinates and manages the technical and operational aspects of projects to secure the successful completion of clinical trials. The team is therapeutically aligned to respond better to customer needs. This role focuses on Nephrology experience in particular, with exposure to dermatology, GI, cardiovascular, rare diseases, diabetes, obesity, and related fields.
We are seeking experienced CTMs who have worked in Nephrology & Transplant as well as NASH & Dermatology. As a Senior Clinical Team Manager, you combine deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. You will own and coordinate the activities of Clinical Management members allocated to a project on a Regional or Country basis, anticipate problems, and deliver results.
You will partner with the Project Manager to ensure training, tracking and quality systems are in place for the clinical management team and will be primarily responsible for the clinical deliverables of the project within agreed timelines and budget. Clinical Team Managers provide contact and support to the project sponsor for all clinical aspects.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award-winning training, and benefits focused on the health and wellbeing of our employees.
Responsibilities
* Manage all clinical operational and quality aspects of allocated studies (moderate to high complexity) in compliance with ICH GCP. May assume Lead CTM or Clinical Study Manager responsibilities on regional levels, or take on additional responsibilities such as process improvements, complex programs, or broader management duties.
* Develop clinical tools (e.g., Monitoring Plan, Monitoring Guidelines) with the Data Quality Plan. Contribute to the Master Action Plan for providing clinical documents. Ensure timely set up, organization, content and quality of the Trial Master File. May participate in CRF design and documentation. Collaborate with the project manager to prepare and present at client meetings.
* Collaborate with the clinical team and other departments to meet deliverables. Lead team meetings to maintain timelines, resources, interactions, and quality. Implement standardized clinical monitoring processes and ensure timely archiving of documents and study materials.
* Ensure achievement of final clinical deliverables within contractual timelines by monitoring activity timelines and metrics, providing status updates, and managing CRF collection and query resolution. Monitor trials for performance and contractual obligations; may conduct Accompanied Field Visits and be accountable for project financials.
* Communicate with study sites regarding protocol, patient participation, case report form completion, and other study-related issues.
* Coordinate start-up activities and ensure essential document quality meets Regulatory Compliance standards. Ensure timely regulatory submissions where appropriate and follow up on ethics committee questions. Responsibilities may vary based on project timelines.
* Provide input for forecast estimates for clinical activities. Manage clinical resources, assignment of responsibilities, and identification of additional resource requirements.
Education and Experience
* Bachelor's degree or equivalent with relevant formal academic/vocational qualification.
* Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 5+ years).
* In some cases, an equivalency of education, training and/or related experience may be considered sufficient.
Knowledge, Skills and Abilities
* Strong leadership and mentoring abilities; capable of motivating and integrating teams.
* Excellent planning and organizational skills for prioritizing workload.
* Strong interpersonal and problem-solving skills for working in a multicultural matrix organization.
* Understanding of change management principles and clinical monitoring practices.
* Judgment, decision-making, escalation, and risk management skills.
* Effective verbal and written English communication skills.
* Ability to evaluate workload against project budget and adjust resources accordingly.
* Financial acumen with budgeting and forecasting knowledge.
* Attention to detail; knowledge of ICH/GCP, FDA guidelines, etc.
* Strong computer skills with Office applications and automated systems.
* Ability to independently manage clinically focused studies.
Working Environment
* PPD values health and wellbeing; we support a healthy, balanced work environment.
* Ability to communicate clearly with diverse groups; work/hour flexibility as required.
* Ability to work in non-traditional environments and use standard office equipment proficiently.
* Ability to work under pressure while prioritizing multiple projects.
* May be exposed to potentially hazardous elements in healthcare or lab environments.
* This role requires independent travel up to 20% (car, air, train).
Our 4i Values
* Integrity – Innovation – Intensity – Involvement
* If you resonate with our 4i values and wish to accelerate the delivery of safe and effective therapeutics for urgent health needs, submit your application – we’d love to hear from you!
We are unable to consider junior applications at this time.
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