Clinical Research Associate

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 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency
Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

Job Summary
We are seeking a dynamic independent and experienced Research Associate in Clinical Management for processing, reviewing and receiving clinical data and records and from therapeutic groups as well as internal and outside investigators. Ensuring accurate, timely, and consistent data reaches the clinical teams and other groups.
 
Roles & Responsibilities

• Responsible to monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols under supervision of Clinical Operations Manager/ Clinical Research Specialist.
• Responsible to perform study site feasibility, qualification, initiation, monitoring and close-out activities (remotely/ on-site) under supervision in line with study specific project management/ sponsor oversight plan and apply judgment and knowledge to independently resolve site issues, questions, and concerns. 
• Support Clinical Operations Manager/ Clinical Research Specialist to prepare for project kick-off/ investigator’s meeting.
• Will be desirous to build and maintain relationships with investigators and site staff. 
• Will be responsible to address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation and communication.
• Responsible for documentations under supervision and ensure maintenance of Trial Master File/ Sponsor Oversight File in line with study specific project management/ sponsor oversight plan. 
• Support study sites in making Ethics Committee submissions under supervision in  line with study specific project management/ sponsor oversight plan. 
• Responsible to review & follow-up on site payments. 
• Assist with data query resolution process for site, Clinical Research organisation (CRO) and Sponsors along with Clinical Data Management in line with study specific project 
• management/ sponsor oversight plan.
• Responsible to work collaboratively with the study teams with the review, revision and writing of protocols, Case Report Forms (CRF) and other required documents for clinical research studies. 

Educational qualification: Master degree in pharmacy/ life science/Biology/Biotechnology/ Biochemistry/Diploma in Clinical Research

Minimum work experience: 2 - 5 years of research 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.
• Understanding of pharmacovigilance processes.
• 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. 

About the Department
Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages
Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.

Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at https://careers.drreddys.com/#!/