Trial management Specialist III
Pharmaceutical Product Development (PPD)
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and implement high-quality, cost-efficient clinical studies.
The PPD FSP Solution:
PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success. Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience. Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.
As a Clinical Team Manager (CTM)/ Local Study Manager, you combine deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. You take ownership, anticipate problems, find solutions and deliver results. You will be fully integrated into the client's SOPs and clinical systems.
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.
Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer.
Interprets data on complex issues and makes good business decisions with support from line management.
Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations.
Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team.
Typically works independently on projects of moderate to high complexity and may assume regional lead or Clinical Study Manager responsibilities.
- Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities.
- Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents.
- Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central).
- May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required.
- Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
- Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained.
- Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. - Responsible for the timely archiving of documents and study materials for the department.
- Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution.
- Continuously monitors clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits(AFVs) and be accountable for project financials.
- Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
- May coordinate all start-up activities and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines.
- Provides input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements. Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Oncology experience & vendor management, including CRO management Previous CTM experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
Knowledge, Skills and Abilities:
- Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
- Strong planning and organizational skills to enable effective prioritization of workload and workload of team members
- Strong interpersonal and problem-solving skills to enable working in a multicultural matrix organization
- Solid understanding of change management principles
- Comprehensive understanding of the practices, processes, and requirements of clinical monitoring
- Strong judgment, decision making, escalation, and risk management skills
- Effective oral and written communication skills, including English language proficiency & the local language for countries outside the UK
- Capable of evaluating own and team members workload against project budget and adjust resources accordingly
- Strong financial acumen and knowledge of budgeting, forecasting and fiscal management - Strong attention to detail
- In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
- Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
- Capable of independently managing clinical only studies
Our 4i values: - Integrity - Innovation - Intensity - Involvement -
If you resonate with our four principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you. Please note only short-listed candidates will be contacted. Work Environment Requirements: PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. PPD® FSP: People Who Deliver | PPD Careers - Read about PPD employee experiences!
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