Sr Ctm

Segmento: Não Informado

Atividades:

We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world's most challenging health concerns.

Our Clinical Research team, who powers our PPD clinical research portfolio, are part of our leading global contract research organization (CRO).

PPD's 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 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), 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.
• 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 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.

Essential Functions:

• 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 such as process improvements, managing complex programs, or wider management roles.
• 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 setup, 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.
• 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 project deliverables.
• Regularly communicates with the team and leads team meetings to ensure 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 policies.
• Responsible for the timely archiving of documents and study materials.
• Ensures achievement of the final clinical deliverable within the contractual time period by monitoring timelines and metrics, providing status updates, reviewing projects, implementing recovery actions, and managing CRF collection and query resolution.
• Continuously monitors clinical trials to assess performance and ensure contractual obligations are met. May conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
• Communicates with study sites regarding protocol, patient participation, case report form completion, and other issues.
• May coordinate all start-up activities and ensure regulatory compliance of documents.
• Ensures timely regulatory submissions and follows up on ethics committee questions.
• Provides input into forecast estimates for clinical activities.

Additional Information:

Days of the week: Not informed

Working hours/Period: Not informed

Interested parties should apply through the Caderno Nacional portal.