Job Title: Technical Officer – Clinical Data Management
Location: Ahmedabad, India
About Lambda Therapeutic Research:
Lambda Therapeutic Research is a leading global Clinical Research Organization (CRO) dedicated to providing comprehensive clinical trial solutions to the pharmaceutical, biotechnology, and medical device industries. With operations spanning across India, the USA, Canada, the UK, Poland, and Spain, we are committed to excellence in clinical research and driving innovation in healthcare.
Job Summary:
We are seeking a highly motivated and detail-oriented Technical Officer to join our Clinical Data Management (CDM) team in Ahmedabad. This position offers an excellent opportunity for individuals with a strong foundation in life sciences or related fields to build a rewarding career in clinical research. As a Technical Officer, you will be involved in critical CDM activities, contributing to the success of global clinical studies. You will gain hands-on experience in eCRF design, data validation, query management, medical coding, and late-phase clinical trials. If you are passionate about data quality, accuracy, and compliance in a fast-paced environment, we encourage you to apply.
Key Responsibilities:
As a Technical Officer, you will be responsible for the following:
- Clinical Data Management:
- Design, test, and update electronic Case Report Forms (eCRFs) to ensure accurate data collection.
- Perform data validation procedures to identify and resolve inconsistencies and errors.
- Execute edit checks to maintain data integrity and compliance with regulatory standards.
- Manage queries and resolve discrepancies in a timely and efficient manner.
- Support the development and maintenance of CDM documentation, including data management plans, standard operating procedures (SOPs), and guidelines.
- Ensure adherence to regulatory requirements, Good Clinical Data Management Practices (GCDMP), and company policies.
- Clinical Research Operations:
- Actively participate in late-phase (Phase II/III/IV) clinical trials.
- Contribute to the planning, execution, and close-out of clinical studies.
- Assist in the preparation of study-related documents, such as study protocols, informed consent forms, and investigator brochures.
- Collaborate with cross-functional teams, including clinical operations, biostatistics, and medical affairs, to ensure the successful conduct of clinical trials.
- Medical Coding:
- Code concomitant medications using standardized medical dictionaries (e.g., MedDRA, WHO Drug Dictionary).
- Ensure accurate and consistent coding of medical terms to facilitate data analysis and reporting.
Required Qualifications:
- Bachelor’s degree in Dental Surgery (BDS), Bachelor of Homeopathic Medicine and Surgery (BHMS), Bachelor of Ayurvedic Medicine and Surgery (BAMS), Master of Pharmacy (M.Pharm), or Master of Science (M.Sc.) in Life Sciences or Clinical Research.
- Strong understanding of medical terminology, clinical trial processes, and regulatory requirements.
- Excellent attention to detail, analytical skills, and problem-solving abilities.
- Effective communication and interpersonal skills to collaborate with cross-functional teams.
- Proficiency in computer skills, including Microsoft Office Suite (Word, Excel, PowerPoint).
Experience Needed:
- Up to 2 years of experience as a Clinical Research Coordinator (CRC) on electronic data capture (eDC) platforms.
- Prior experience working in a CDM department as a Data Manager or Data Validator is an added advantage.
- Familiarity with clinical data management systems (CDMS) such as Medidata Rave, Oracle Clinical, or similar platforms is desirable.
Benefits & Growth Opportunities:
- Opportunity to work with a global CRO with operations in multiple countries.
- Mentorship from experienced professionals in clinical data management.
- Exposure to multinational Phase II/III/IV clinical studies across various therapeutic areas.
- Competitive salary package: ₹3,00,000 – ₹5,00,000 per annum.
- Comprehensive benefits package, including health insurance, paid time off, and retirement plan.
- Career progression opportunities within CDM, medical coding, or clinical operations based on performance and interests.
- Training and development programs to enhance your skills and knowledge.
To Apply:
If you meet the qualifications and are interested in this exciting opportunity, we encourage you to apply. Please submit your resume and cover letter.
We are an equal-opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.