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.

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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

• Responsibilities

• Facilitate Study Start up activities at Clinical Investigational Site
• Conduct Feasibility & assess the data
• Conduct site qualification visits to assess suitability of sites for study conduct including review of Investigator qualifications, site staff adequacy, site facilities, patient pool & share feedback to project team
• Collection of essential documents including validation records for site equipment from selected sites for regulatory and EC submissions
• Identify the training needs for the site to perform adequate conduct of trial
• Ensure supply of clinical trial material to sites before study initiation
• End to End clinical investigational site management:
• Initiate the study at clinical investigational sites
• Provide study protocol and related trainings
• Perform review of Informed Consent forms and narrative
• Perform review of source records, perform SDV
• Review of CRF data entry, data queries and coordinate with sites to resolve
• Ensure timely completion and review of site visit reports and addressing action items via follow up letters, tracking of action items till closure
• IP accountability and reconciliation
• Ensure adequate initial supply & re-supply of IP per study plan to clinical trial sites
• Provide adequate oversight to IP collection, storage, temperature monitoring including review of log, administration to study subjects
• Identification of any temperature excursions and suitability of IP for subject administration
• Ensure destruction of expired / used IP on site or return of such IP back to local depot, per study requirement & adequate documentation for same.
• Review of completion of logs, filing of relevant shipment etc. documentation in site / pharmacy file.
• Site Contracts and Site Payment Coordination
• Coordinate for CDA, Clinical trial agreements review and finalization and amendments, as applicable
• Ensure that site invoices are being generated as per clinical trial agreement
• Review and approval of site invoices and submission to payment processing team
• Coordinate for the payment release & confirm for site acknowledgements
• Perform ongoing reconciliation of payments against site activities including subject visits conduct etc.
• Liaising with safety lab for timely samples receipt, processing and release of reports & identify, resolve any issues / risks around same.
• Ensure that the Bio-analytical samples are stored as per storage conditions mentioned in the lab manual including reconciliation and query resolution
• Liaising with other vendors and help sites in any query resolutions for vendor related activities
• Liaising with internal project teams including but limited to Data Management for EDC issues, data queries and reconciliations, Safety team for SAE related issues, Medical team for any protocol / eligibility related queries etc.
• Liaising with Internal & External Stakeholders
• Ensuring Compliance to Protocol & Applicable study plans, SOPs, GCP and regulatory requirements
• Ensure compliance to Protocol
• Ensure compliance to study plans, applicable SOPs and related regulatory requirements
• Ensure compliance to ICH GCP
• Ensure compliance to good documentation practices including ALCOA-C
• Identification of significant deviations to protocol / plans / procedures, escalation to project lead / clinical ops lead and propose adequate mitigation plans / CAPA, Review of implementation of CAPA / mitigation plans, identify need for training and provide training / re-training in case of any changes
• Support audits, inspections / QC visits, as required per study plans
• Trial Master File Review and Maintenance for Inspection Readiness
• Ensure that sites are timely updating the documents in Investigator site file
• Retrieval of essential documents from sites for In house filing / Central files
• Review of onsite and in house files at defined frequency per monitoring / TMF plan for study
• Ensure adequacy of TMF for all time inspection readiness

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
Biologics
Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon.
With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.

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/#!/