Job Description

Work Schedule Standard (Mon-Fri)
Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards

The Clinical Data Team Lead (CDTL) position at Trialmed (a global site network and the early phase clinical solution for PPD, the clinical research business of Thermo Fisher Scientific Inc.) offers an exceptional opportunity to work with a global team and lead world-class data management projects that drive scientific research forward. As a CDTL, you will serve as the lead data manager for one or more projects, emphasizing flawless execution and strict adherence to project protocols.
Key Responsibilities

• Lead all data management activities for individual, limited volume/complexity studies with support from senior team members.
• Act as an interdepartmental liaison to the Project Lead and/or client as required and communicate with management regarding all data management (DM) activities within their studies.
• Apply relevant components of the project protocol to daily tasks and direct others on how to apply them.
• Develop and maintain data management project documentation files; perform independent reviews of data management deliverables following documented CDM guidelines.
• Serve as the point person and subject matter expert for specialized study-specific processes.
• Develop and deliver study-specific training for DM project staff. Mentor junior level staff on all associated tasks within a study.
• Produce project-specific status reports for management, Project Lead, and/or clients on a regular basis. Monitor study metrics.
• Contribute to the improvement of data management processes on a global level.
• Participate in business development activities by assisting with bid preparation and/or representing data management at bid defense meetings, where required.
• Assist with project forecasting of hours and identification of resource requirements. Identify potential out-of-scope activities to Project Lead and management and assist with the Contract Modification process.
• Assist with the administrative and financial management of allocated projects. Perform all assigned data management activities independently and efficiently, with attention to quality.
• Perform data management activities such as Serious Adverse Event and Third-Party Vendor reconciliations, as well as Data Listing reviews.
• Perform advanced aspects of the data cleaning process with high accuracy, in accordance with GCPs and SOPs/WPDs, to assess the safety and efficacy of investigational products and/or medical devices.
• Work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Develop professional expertise, applying company policies and procedures to resolve a variety of issues.
• Receive general instructions on routine work and detailed instructions on new projects or assignments. Exercise judgment within defined procedures and practices to determine appropriate action.
• Build productive internal/external working relationships, with contacts primarily internal to the company and infrequent external customer/vendor contact on routine matters.

Education and Experience

• Bachelor's degree or equivalent formal academic qualification.
• Minimum of 6+ years of experience in data management or a related field.
• Combination of education, training, and relevant experience may be considered sufficient.

Knowledge, Skills, and Abilities

• Apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs, and client expectations.
• Strong attention to detail, numerical skills, and proficiency with interactive computer programs, including Microsoft Office applications.
• Excellent written and verbal communication skills with a strong command of the English language and grammar.
• Good organizational, analytical, and problem-solving skills, capable of working productively with moderate supervision.
• Fast and agile learner, capable of quickly adapting to new information and environments, including the use of Generative AI tools.
• Effective interaction with global teams, demonstrating strong interpersonal skills, cultural awareness, and a strong customer focus.
• Ability to train and direct study team.
• Ability to set and meet timelines or recognize and schedule changes in response to project demands.
• Proactive and self-motivated, with excellent time management skills and the ability to organize tasks efficiently and adhere to schedules.
• Experience with DM EDC databases, particularly Medidata Rave and Veeva Vault, and knowledge of good documentation practices such as eTMF.
• Ability to maintain a high degree of confidentiality with clinical and proprietary data.
• Flexibility and adaptability, capable of working in a team environment or independently, demonstrating good judgment in decision-making.
• Knowledge of medical/clinical trial terminology and understanding of project protocols and Data Validation Manual.

Working Conditions

• The standard working hours are from 1:00 PM to 10:00 PM IST.
• Employees have the flexibility to choose between office, remote, or hybrid work options.

Join us in our mission to make the world healthier, cleaner, and safer by successfully implementing your expertise in data management. Apply today and become part of our ambitious team at Trialmed (a global site network and the early phase clinical solution for PPD, the clinical research business of Thermo Fisher Scientific Inc.).

Skills Required