Sr Clinical Team Manager CTM - Non Interventional Studies NIS

(Senior) Clinical Team Manager Non Interventional Studies

PPDs (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 inbetween its you! We know that meaningful results not only require the right approach but also the right people. We invite you to reimagine health promoting protocols with us working alongside our dedicated forwardthinking and energetic teams.

Our noninterventional Peri and Post Approval Research Operations group consists of colleagues with institutional knowledge broad and indepth therapeutic experience and robust operational tools to help our clients deliver lifechanging therapies to market. You take ownership anticipate problems find solutions and deliver results.. Together we help clients define and develop clinical programs minimize delays and implement highquality costefficient clinical studies.

As a Clinical Team Manager (CTM) you combine deep knowledge therapeutic expertise and robust tools to help our clients deliver lifechanging therapies to market. You take ownership anticipate problems find solutions and deliver results. You take ownership anticipate problems find solutions and deliver results; coordinating the activities of Clinical Management 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 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 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 customers 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.

Essential Functions:

• Leads 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 lead 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 handoff 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 leading 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 studyrelated issues.
• May coordinate all startup 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:

• Bachelors degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 8 years).
• Global study experience is highly preferred. Non Interventional studies and/or Real World Evidence experience is also preferred. The team would also consider strong experience in oncology and gene therapy.
• 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 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 problemsolving 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 critical issue 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 skill and knowledge of budgeting forecasting and fiscal management
• Strong attention to detail
• Indepth 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 leading 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 nontraditional 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 worlds most urgent health needs submit your application wed love to hear from you!