[Remote] Sr Clinical Data Associate at Thermo Fisher Scientific

India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

Bachelor’s degree or equivalent formal academic qualification
Minimum of 3+ years of experience in data management or a related field (combination of education, training, and relevant experience may be considered sufficient)
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 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
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

Responsibilities

Supports the setup of study activities such as database design, testing of data entry screens, and Data Validation Manual (DVM) creation, as required
Identifies, resolves, and updates data discrepancies, making necessary changes to the data management database
Generates, tracks, and resolves data clarifications and queries; may implement CRF design in identified graphic design package
Reviews data listings for accuracy and consistency, analyzing and resolving data validation and other data management reports
Acts as point person and subject matter expert for specialized study-specific processes
Provides training and work direction to junior staff as required
Contributes to the improvement of data management processes on a global level
Produces project-specific status reports for CDM management and clients regularly
Performs data management activities such as Serious Adverse Event and Third-Party Vendor reconciliations, as well as Data Listing reviews
Performs 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
Works on difficult or complex assignments requiring considerable judgment and initiative to resolve issues, understanding the implications of work and making recommendations for solutions and/or new procedures
Completes tasks resourcefully and creatively, contributing to the development of concepts and techniques
May act independently in determining methods and procedures on new assignments, potentially serving as a facilitator and/or team leader (formal or informal)
Frequently contacts individuals representing outside organizations or of significant importance within the company, involving planning and preparation of communications requiring skill, tact, persuasion, and/or negotiation to accomplish objectives

Skills

Clinical Data Management

Database Design

Data Validation

Query Management

CRF Design

Data Cleaning

GCP

SOP

Serious Adverse Event Reconciliation

Third-Party Vendor Reconciliation

GMP

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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