Clinical Trial Associate

4 months ago

Mumbai Maharashtra, India Atnahs Full time

**Mumbai or Vadodara, India (hybrid: 3 days office, 2 days home)**:
**Salary: Competitive + Benefits + Bonus**:
If you are an agile, committed, and innovative clinical trial professional, then we want to hear from you

Join us to help improve peoples’ lives and make healthcare better for everyone

**Why Pharmanovia?**:
Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

**Our core behaviours are**:

- We act decisively but we never compromise on quality.
- We keep our promises and do as we say.
- We value our heritage and foster an entrepreneurial spirit.
- We reinvest in our future - in our products, our brands and our people.
- We give back to our communities.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, Spain, and South Korea.

We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

Pharmanovia’s therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

**About the role**:
As Clinical Trial Associate you will support the Clinical Trial Manager and Real-World Evidence Trial Manager in the effective documentation and coordination of logístical aspects of assigned trials, and act as a pivotal point of contact and support for the trial team.

Reporting to the Head of Clinical Development, you will take a leading role in the creation and maintenance of study documents. In addition, this is an important role in supporting the development and maintenance of the Clinical Quality Management System ensuring SOPs, policies, manuals and staff training records are kept complete and up-to-date, and that the QMS reflects current and best practice.

Our Clinical Development Department has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.

**Main responsibilities & duties**:

- Responsibility for ensuring that the Sponsor Oversight File (SOF) and/or the Trial Master File (TMF), to include electronic TMFs, is complete and accurate on an ongoing basis and ready for archiving according to timelines
- Performing/overseeing periodic QC of SOFs and/or TMFs at Pharmanovia to ensure completeness and accuracy
- Performing QC of any TMF maintained by Service Providers (SPs) during and at the end of a study as well as an evaluation of the SPs TMF processes before study initiation
- Maintaining and updating any electronic study folders to ensure eFiles reflect any paper TMF/SOF and vice versa
- Support with clinical archiving to ensure timely coordination of archiving study documentation.
- Arranging and participating in the organisation of Investigator Meetings & Study Team Meetings (internal and external), preparing agendas and taking (where appropriate) and distributing minutes as required
- Coordinating any study document reviews where required
- Assisting with the Ethics submissions; keep a track of submissions & approvals for the study. Liaise with Regulatory Affairs to ensure linkage with regulatory approvals
- Printing, distributing, and tracking of any study specific documents internally and to any SPs
- Creating and maintaining study contact lists and relevant information databases for study team
- Sending out Study Newsletters / Study Correspondence to all participating SPs/sites on an ongoing basis
- Facilitating and tracking any study payments following the internal approval process
- Facilitating the obtaining and maintenance of study insurances
- Conduct oneself at all times in accordance with Pharmanovia Quality Management System, company working practices and policies, applicable GxP regulations ensuring training in these areas is kept up to date at all times
- Assisting with the company’s Clinical Quality Management System:

- Reviewing, updating, and expanding Standard Operating Procedures and associated documents, policies, and manuals
- Ensuring staff are awa

  • Clinical Trial Associate

    5 months ago

    Mumbai, Maharashtra, India Atnahs Full time

    **Vadodara or Mumbai, India (hybrid: 3 days office, 2 days home)**: **Salary: Competitive + Benefits + Bonus**: If you are an agile, committed, and innovative clinical trial professional, then we want to hear from you! Join us to help improve peoples’ lives and make healthcare better for everyone! **Why Pharmanovia?**: Pharmanovia is a dynamic,...

  • Clinical Trial Associate

    5 months ago

    Mumbai, India Novartis Full time

    100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine -...

  • Clinical Trial Monitor

    5 months ago

    Mumbai, Maharashtra, India Bristol-Myers Squibb Full time

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Clinical Trial Manager

    1 month ago

    mumbai, India IQVIA India Full time

    Job Title: : Clinical Trial ManagerTherapeutics Area Experience : Oncology therapeutics experience is a mustJob Summary:Local Trial Management services provides local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned protocol(s) at the...

  • Clinical Trial Manager

    1 month ago

    Mumbai, India IQVIA India Full time

    Job Title: : Clinical Trial Manager Therapeutics Area Experience : Oncology therapeutics experience is a must Job Summary: Local Trial Management services provides local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned protocol(s) at...

  • Clinical Trial Manager

    1 month ago

    mumbai, India IQVIA India Full time

    Job Title:: Clinical Trial ManagerTherapeutics Area Experience : Oncology therapeutics experience is a mustJob Summary:Local Trial Management services provides local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned protocol(s) at the country...

  • Clinical Trials

    6 months ago

    Maharashtra, India Diabetes Unit KEM Hospital Pune Full time

    Clinical trials are the actual experimental studies in which human volunteers are included, after their consent, to test new treatments, instruments, Read More

  • Clinical Trial Assistant

    4 months ago

    Aurangabad, Maharashtra, India Vertex Business Solutions Full time

    As a Clinical Trial Assistant (CTA) at [Company Name], you will play a crucial role in supporting the successful execution of clinical trials. Working closely with the clinical operations team, you will provide administrative and operational assistance to ensure the smooth conduct of trials from initiation to closeout. **Key Responsibilities**: - Maintain...

  • Clinical Research Associate

    4 months ago

    Pune, Maharashtra, India Ascentrik Research Pvt Ltd Full time

    **Job Type - Fresher or Internship level** Clinical Research Associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures. A Clinical Research Associate, also known as a CRA, conducts research to ensure these products are safe. **Responsibilities**: **1. Assist in Protocol Development**: -...

  • Clinical Research Associate

    5 months ago

    Pune, Maharashtra, India Ascentrik Research Pvt Ltd Full time

    **Job Type - Fresher or Internship level** Clinical Research Associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures. A Clinical Research Associate, also known as a CRA, conducts research to ensure these products are safe. **Responsibilities**: **1. Assist in Protocol Development**: -...

  • QA - Clinical Trials

    4 months ago

    Mumbai, Maharashtra, India Acme Services Full time

    **Roles & Responsibilities** - Conduct audits of clinical trail study - Conduct operations as per SOP - Conduct vendor audits - Maintain Quality system for clinical trial unit - Maintain relevant documentation **Criteria** Minimum of **2-5 years of experience** in pharmaceutical industry **Salary**: ₹35,000.00 - ₹58,000.00 per month Application...

  • Clinical Trial Assistant

    4 months ago

    Mumbai, Maharashtra, India Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Research Faculty

    5 months ago

    Borivali, Mumbai, Maharashtra, India Clinomic Center For Clinical research Full time

    all Clinical Research Topic: - DRUG DEVELOPMENT: FROM MOLECULE TO PRESCRIPTION: PART 1 DRUG DEVELOPMENT: FROM MOLECULE TO PRESCRIPTION: PART 2 THE EVALUTION OF THE CLINICAL TRIAL PROCESS-A BRIEF HISTORY LESSON HISTORICAL BACKGROUND OF GCPINSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)STAKEHOLDERS ENGAGEMENT TO ENSURE A SUCCESSFUL TRIAL...

  • Clinical Research Associate

    5 months ago

    mumbai, India REGROW BIOSCIENCES Full time

    Overview:As a Clinical Research Associate (CRA), you will play a pivotal role in the development and execution of clinical trials Working closely with research teams, regulatory bodies, and clinical sites, you will ensure compliance with protocols, regulatory requirements, and industry standards throughout the trial process.Responsibilities:1 . Trial...

  • Clinical Research Associate

    5 months ago

    Mumbai, India REGROW BIOSCIENCES Full time

    Overview:As a Clinical Research Associate (CRA), you will play a pivotal role in the development and execution of clinical trials Working closely with research teams, regulatory bodies, and clinical sites, you will ensure compliance with protocols, regulatory requirements, and industry standards throughout the trial process.Responsibilities:1.Trial...

  • Clinical Research Associate

    5 months ago

    Mumbai, India REGROW BIOSCIENCES Full time

    Overview: As a Clinical Research Associate (CRA), you will play a pivotal role in the development and execution of clinical trials Working closely with research teams, regulatory bodies, and clinical sites, you will ensure compliance with protocols, regulatory requirements, and industry standards throughout the trial process. Responsibilities: 1 . Trial...

  • Clinical Research Associate

    1 month ago

    mumbai, India REGROW BIOSCIENCES Full time

    Overview:As a Clinical Research Associate (CRA), you will play a pivotal role in the development and execution of clinical trials Working closely with research teams, regulatory bodies, and clinical sites, you will ensure compliance with protocols, regulatory requirements, and industry standards throughout the trial process.Responsibilities:1.Trial...

  • Clinical Research Associate

    5 months ago

    Mumbai, India REGROW BIOSCIENCES Full time

    Overview:As a Clinical Research Associate (CRA), you will play a pivotal role in the development and execution of clinical trials Working closely with research teams, regulatory bodies, and clinical sites, you will ensure compliance with protocols, regulatory requirements, and industry standards throughout the trial process.Responsibilities:1.Trial...

  • Clinical Research Associate

    2 months ago

    Mumbai, India REGROW BIOSCIENCES Full time

    Overview: As a Clinical Research Associate (CRA), you will play a pivotal role in the development and execution of clinical trials Working closely with research teams, regulatory bodies, and clinical sites, you will ensure compliance with protocols, regulatory requirements, and industry standards throughout the trial process. Responsibilities: 1 . ...

  • Clinical Trial Coordinator

    2 weeks ago

    Mumbai, Maharashtra, India Marken Full time

    Job Title: Clinical Trial CoordinatorJob Summary:We are seeking a highly organized and detail-oriented Clinical Trial Coordinator to join our team at Marken. As a Clinical Trial Coordinator, you will be responsible for providing exceptional customer service and operational support to our clients and internal teams.Main Responsibilities:Monitor shipments on a...