Clinical Research Physician

3 weeks ago

Bengaluru, India Biocon Biologics Full time

JOB DESCRIPTION

- Effectively support the Clinical strategy from TPP till submission of the dossier to regulatories like (FDA, EMEA, DCGI,…) in the

- Prepares/Reviews CDP, IB, study protocols, ICF, briefing book for scientific advices, TLFs and CSRs - Actively work towards approaches for faster completion of trials and having a patient centric approach..

- Provides/Reviews medical inputs for study conduct as per applicable GCP, SOP and regulatory requirements.

- Provides inputs on study level data including GCP-issues report.

- Attends regular meetings with CRO and/or other vendors.

- Supports and oversees activities of study conduct e.G. site selection, interaction with investigators and other service providers.

- Accountable for accuracy of trial information in all trial Registries such as Clinical Trials Registry – India (CTRI), Clinicaltrials.Gov etc.

- Contributes to medical aspects and take part in study initiation and investigator meetings.

- Provides inputs in to protocol deviation decision.

- Medical monitoring which includes data reviews, EDC reviews.

- Oversees CRO and conducts study specific medical monitoring which includes review of daily lab alerts and SAEs to communicate with CRO regarding follow-up.

- Supports audits and inspections.

- Monitors safety of subjects participating in clinical trials.

- Supports pharmacovigilance department in preparing safety documents.

- Supports statistics team in the conduct of Data Safety Monitoring Board interim analysis meetings.

- Prepares/Reviews IND / IMPD medical documents, annual updates, MAA/CTD and other regulatory

- Supports in DBL (provide inputs on Tables, Listings and Figures, actively participate DBL meetings).

- Prepares/Reviews Protocol Synopsis, Safety forms etc.

- Prepare/ Reviews study documents e.G. SAP, DMP, SMP, DSMB charter, MMP, Imaging charter.

- Provides inputs on final TLFs, works with medical writer to review & revise CSR document, draft discussion and conclusions, participate in comment resolution meetings.

- Support Regulatory scientific meetings and MAA approvals (USFDA/EMA/PMDA/CDSCO and other regulatory authorities across different regions and countries) for clinical aspects.

- Supports in Handling of Regulatory, Marketing or any other molecule-related queries

- Supports department activities like SOP preparation and review / external potential partner scientific discussions / consultant interaction.

- Supports in the dissemination of important scientific information through articles or presentations or training.

- Performs other related duties as assigned.

- Provide scientific /Medical rationale or justification on specific products or therapy area

  • Clinical Research Associate

    4 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title : Clinical Research Associate (CRA) Company : MS Clinical Research Pvt Ltd Experience : Minimum 3 years About Us : MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to conducting high-quality clinical trials and contributing to the...

  • Clinical Research Associate

    4 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title : Clinical Research Associate (CRA) Company : MS Clinical Research Pvt Ltd Experience : Minimum 3 years About Us : MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to conducting high-quality clinical trials and contributing to the...

  • Clinical Research Associate

    3 weeks ago

    Bengaluru, Karnataka, India, Karnataka MS CLINICAL RESEARCH Full time

    Job Title: Clinical Research Associate (CRA)Company: MS Clinical Research Pvt LtdExperience: Minimum 3 yearsAbout Us:MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to conducting high-quality clinical trials and contributing to the...

  • Senior Clinical Research Associate

    6 days ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Senior Clinical Research Associate (Sr. CRA)Company: MS Clinical Research Pvt LtdExperience: Minimum 5 yearsAbout UsMS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of...

  • Senior Clinical Research Associate

    2 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Senior Clinical Research Associate (Sr. CRA)Company: MS Clinical Research Pvt LtdExperience: Minimum 5 yearsAbout UsMS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of...

  • Senior Clinical Research Associate

    2 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Senior Clinical Research Associate (Sr. CRA)Company: MS Clinical Research Pvt LtdExperience: Minimum 5 yearsAbout UsMS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of...

  • Senior Clinical Research Associate

    2 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Senior Clinical Research Associate (Sr. CRA)Company: MS Clinical Research Pvt LtdExperience: Minimum 5 yearsAbout UsMS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of...

  • Senior Clinical Research Associate

    2 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Senior Clinical Research Associate (Sr. CRA)Company: MS Clinical Research Pvt LtdExperience: Minimum 5 yearsAbout UsMS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of...

  • Senior Clinical Research Associate

    1 week ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Senior Clinical Research Associate (Sr. CRA)Company: MS Clinical Research Pvt LtdExperience: Minimum 5 yearsAbout UsMS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of...

  • Senior Clinical Research Associate

    2 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Senior Clinical Research Associate (Sr. CRA)Company: MS Clinical Research Pvt LtdExperience: Minimum 5 yearsAbout UsMS Clinical Research (MSCR) is a leading clinical research organization committed to advancing scientific innovation and improving healthcare outcomes. We conduct high-quality clinical trials that adhere to global standards of...