[Remote] Clinical Data Team Lead at Thermo Fisher Scientific

India

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, BiotechnologyIndustries

Requirements

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
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

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

Skills

Key technologies and capabilities for this role

Data ManagementCDMGMPProject ManagementProtocol AdherenceStudy MetricsTraining DeliveryMentoringStatus ReportingBusiness DevelopmentBid PreparationResource Forecasting

Questions & Answers

Common questions about this position

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for the Clinical Data Team Lead role?

This information is not specified in the job description.

What key skills are required for the Clinical Data Team Lead position?

Key skills include leading data management activities, applying project protocols, developing documentation, mentoring junior staff, performing data cleaning and reconciliations with high accuracy per GCPs and SOPs, and monitoring study metrics.

What is the work schedule for this role?

The work schedule is standard Monday through Friday.

What experience makes a strong candidate for this Clinical Data Team Lead role?

Strong candidates have experience leading data management for studies, mentoring junior staff, handling advanced data cleaning and reconciliations, and contributing to process improvements and business development.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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