Senior Clinical Trial Manager (Sr. CTM)

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description PPD’s (a part of Thermo Fisher Scientific) mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams. Our therapeutic team directs, coordinates and manages the technical and operational aspects of projects, securing the successful completion of clinical trials. The team is therapeutically aligned to respond better to our customer needs. The therapeutic scope includes Cardiovascular & Internal Medicine - Dermatology, GI, (UC/CD), Cardiovascular, Liver, Nephrology, Immunology, Rare Disease, Diabetes, Obesity, Dyslipidemia, Women's Health. As a Senior Clinical Team Manager (Sr. CTM), you combine deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. You take ownership of all start-up and clinical deliverables, anticipate problems, find solutions and deliver results; coordinating the activities of start-up and clinical team members which are allocated to a project on a Regional or Country basis. You will work in partnership with the Project Manager to ensure the necessary training, tracking and quality systems are in place for the clinical management team and be primarily responsible for the start-up and 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. Summarized Purpose: Accountable for achieving the final start-up and clinical deliverables (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 start-up and clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring start-up and clinical activity is conducted within contract scope, through efficient management of the country start-up and clinical team. Typically works independently on projects of moderate to high complexity and may assume regional lead or Clinical Study Manager responsibilities. Essential Functions: Manages all clinical and start-up activities, 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. Acts as the primary point of contact for study start-up activities and site activation across the assigned region and/or globally, driving timelines and ensuring operational excellence. Develops start-up and clinical tools (e.g. Essential Document Checklist, Monitoring Plan, Monitoring Guidelines) in conjunction with the study requirements and 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 start-up country team, regulatory, 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 start-up and clinical deliverable within the contractual time period specified by preparing and monitoring start-up and 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. Coordinates 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 start-up and clinical activities. Responsible for start-up and 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 Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Strong experience managing end-to-end clinical trial start-up (SSU) activities, particularly within the APAC region. Experience leading cross-functional collaboration with CAS, RAL, ICF PM, GCS, Contract Management, and other stakeholders to ensure seamless study execution. 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 start-up and clinical monitoring Strong judgment, decision making, escalation, and risk management skills Effective oral and written communication skills, including English language proficiency 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 Working Environment: PPD, a part of Thermo Fisher Scientific, values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments. This role requires independent travel up to 20%, inclusive of traveling in automobiles, airplanes, and trains. Our 4i Values: Integrity – Innovation – Intensity – Involvement If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!