Clin Data Assoc II

Work Schedule

Environmental Conditions

Job Description

CDA II:

Join Us as a Clinical Data Associate I Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 Bio-techs spanning 2700 clinical trials across 100 countries in the last 5 years.

Role 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 Requirements:

• Bachelors degree or equivalent and relevant formal academic
• Previous experience (Min 1.6 to 3 Years) that provides the knowledge skills and abilities to perform the job
• Should 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 clients 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 landscape
• Global 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 world healthier cleaner and safer. Whether our customers are accelerating life sciences research solving sophisticated analytical challenges improving patient diagnostics and therapies or making their laboratory work more efficient we are here to support them. Our distributed team of more than 90000 colleagues delivers an outstanding combination of innovative technologies purchasing convenience and pharmaceutical services through our industry-leading brands including Thermo Scientific Applied Biosystems Invitrogen Fisher Scientific Unity Lab Services and Patheon. For more information please visit. Thermo Fisher Scientific is a Equal employment opportunity