01Role Overview
As a Clinical Data Associate II, you will lead advanced data review and cleaning activities to drive data integrity, timeliness, and inspection readiness across assigned studies. Operating under GCP and SOPs/WPDs, you will manage complex queries, perform SAE and thirdparty data reconciliations, review data listings and validation outputs, and contribute to CRF design and database updates. Partnering with crossfunctional teams, you will produce clear status reports for stakeholders, proactively resolve issues and risks, and ensure highquality, analysisready datasets that support accurate assessment of safety and efficacy.
What Youll Do:
Identify, resolve, and update data discrepancies. Make changes to the data management database as required.Generate, track and resolve data clarifications and queries. May implement CRF design in identified graphic design package.Review data listings for accuracy and consistency of data. Analyze and resolve data validation and other data management reports.Produce project-specific status reports for CDM management and for clients on a regular basis.Perform data management activities such as Serious Adverse Event and Third Party Vendor reconciliations as well as Data Listing reviews.
Education and Experience
02Requirements
Bachelor's degree or equivalent and relevant formal academic4+ Years of experience in Clinical Data Manager role is requiredShould have experience in RAVE / Veeva EDC
Knowledge, Skills and Abilities:
Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations
Strong attention to detail and skill with numbers and ability to use interactive computer programs
Good written and verbal communication skills and a strong command of English language and grammar
Good organizational and analytical/problem-solving skills
Ability to work productively with moderate supervision
Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
Strong customer focus and excellent interpersonal skills.
Proven flexibility, adaptability and ability to work in a team environment or independently as needed
Must demonstrate good judgment in making decisions
Knowledge of medical/clinical trial terminology
Understands project protocol and Data Validation Manual
Working Conditions and Environment:
Work is performed in an office or clinical environment with exposure to electrical office equipment.
Occasional drives to site locations. Potential Occasional travel required.
Your Career Growth:
We are hiring a team in India to support our FSP client - a large, globally recognized biopharmaceutical organization with a strong legacy in specialty medicines, vaccines, and scientific innovation. This sponsor is known for its commitment to patients, global research and development, and long-term investment in science. As a client dedicated FSP employee, you will collaborate with our clients global data science team, contribute to complex and high visibility initiatives, and work within a mature FSP delivery model focused on quality and partnership.
Our FSP model supports continuous learning and career development by offering employees tailored learning pathways, stretch assignments, and mentorship this allows FSP professionals to expand their horizons. This role opens multiple career paths. You could progress along the Clinical Data Management track (e.g., Senior CDM, CDTL, CDM PM) or transition into Data Standards/Programming, based on skill, impact, and business need.
Why Youll Want to Join:
Join our FSP Data Management team and help bring lifechanging medicines to patients worldwide. Accelerate your growth with handson experience in modern CDM, from EDC and data quality to AIenabled workflowsbuilding the expertise to lead datadriven study delivery in a rapidly evolving clinical landscapeGlobal exposure: Work on international clinical studies across phases and therapeutic areas, partner with global teams, CROs, vendors, and country operations.
End-to-end ownership: Contribute to every stage of study delivery, from set-up to close-out.
Analytical & project skills: Strengthen global project management, financial tracking, data analysis, and risk management abilities. Learn new clinical trial technologies like AI platforms to conduct a global clinical trial
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the .
