Clinical Trial Associate Job at Dr. Reddy’s Laboratories – Apply Now!
Clinical Trial Associate
Hyderabad, Hyderabad, India
Full-time
Job Family: Clinical Development
Sub Job Family: Clinical Operation
Business unit: Biologics
Years of Experience: 1 – 3
Company Description
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait. We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets). ‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by
Job Description
Job Summary
The Clinical Trial Associate (CTA) supports clinical studies and the Clinical Operations Department, in managing various administrative tasks such as generation of agenda and minutes, maintaining study tracking, filing and quality reviews as well as participating to process improvement initiatives across the departments.
Roles & Responsibilities
- Provide general administrative support to the Clinical Operations Department and assistance to the study team(s).
- Assist in the production of presentations as needed for project, departmental, and/or business development.
- Assists the team with Sponsor oversight, study specific documentation review and QC including review of ICF, study plans, study reference manuals, e-CRF, etc.
- Assist with creation and maintenance of study metrics trackers, tools and reports.
- Assist in co-ordination and tracking of Investigator and third-party payments.
- Ensures required study documents are submitted to the eTMF.
- Assists the team with Sponsor oversight of eTMFs periodic audit and findings resolution.
- Assist the team in executing clinical monitoring oversight.
- Assists with customisation of CDA, clinical site contracts & budgets, when applicable.
- Assist the clinical team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
- Co-ordinate document translation, if required.
- May participate in training CRO teams and in the on-boarding of new CRO team members.
- May contact clinical sites for specific requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc. when requested).
- Attends internal and external team meetings/teleconferences and generate meeting agenda and minutes when needed.
- Other duties may be assigned as required.
- If required, the candidate should be willing to travel as needed (<5%).
Qualifications:
Educational Qualification: Graduate/Master degree in pharmacy/life science/ Biology/Biotechnology/Biochemistry/Diploma in Clinical Research
Minimum work experience: 1 – 3 years of Clinical Trial experience
Skills & attributes:
Technical Skills
- Experience in Clinical Trial operations.
- Proficiency in conducting Market research and analysis.
- Knowledge of regulatory requirements and guidelines such as Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
- Ability to evaluate medical research data and proficient knowledge of medical terminology.
- Proficiency in using EDC systems for data collection and management in clinical trials.
- Strong MS office Skills.
Behavioral Skills
- Excellent communication, negotiation, and interpersonal skills.
- Excellent project management skills.
- Strong analytical and problem-solving abilities with a keen eye for detail.
- Result oriented and passionate about delivering value.
Keywords: Clinical Trial Associate, Clinical Trial Job, Pharmaceutical Company Job, Clinical Development, Clinical Operations, Biologics, Hyderabad, India. Clinical Trial Associate Job at Dr. Reddy’s Laboratories – Apply Now! Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook