Sr. Regional Trial Lead

2 weeks ago

gurugram, India SUN PHARMA Full time

Job Summary

RTL/Sr. RTL is responsible and accountable for deliveries of studies allocated to RCO unit, performing end to end study related project management for studies managed in-house with-in agreed timelines, budget and desired quality standards. For Outsourced study, RTL/Sr. RTL will be responsible to provide an efficient Sponsor Oversight and accountable for key deliverables and study success.

RTL/Sr. RTL is expected to adhere to required procedures and quality in compliance with Sun Procedural Documents, ICH-GCP and local regulations.

Area Of Responsibility

Planning and Execution of trials as per agreed timelines, budget and ensuring Quality across processes. Planning and Facilitating HA submission in coordination with IRA team Perform Preliminary site feasibilities, ensure site database is updated on periodic basis with feasibility results Plan and Accountable for the conduct of Site Selection visits, ensure actions from SSV’s are followed up. Planning and performing IRB submissions in an efficient manner to secure timely approvals, ensure IRB/IEC dossiers are prepared and submitted as per requirements. Ensure Translation process are followed up for all trial related documents Track all vendor related payments and ensure timely payments Negotiate study budgets with sites, ensure Clinical Trial Agreements are executed in timely manner Ensure CTRI related submissions and updates in a timely manner for respective projects. Facilitate SUGAM related submissions and updates with IRA team. Responsible for preparing all project plans prior to SIV and training trial teams on the plans. Ensure implementation of plans and updates if required during the course of trial. Ensure planning and conduct of Monitoring visits as per Monitoring plan, devise study specific remote monitoring plans and guidelines. Provide periodic updates to management on study progress, deliverables, risks and Quality. Collaboration and lead communication with cross-functional units (IRA, clinical sciences team, Quality, DM, and other stakeholders to ensure proper execution and conduct the study effectively. Ensure IMP supplies are adequate at depot and site level, coordinate promptly with IMP supply team for initial and resupply orders, manage IP supply scheme at site as per recruitment progress, ensure IMP supplies are received by sites in good condition. Management of all study supplies like Ancillary supplies, e-diaries, recruitment and retention materials, Lab kits, others Plan and track recruitment / retention strategies at study and site level, ensure recruitment risks are communicated pro-actively to management and actions are planned in a timely manner. Ensure compliance with data cleaning cycles, train and update CRA’s on data cleaning requirements. And, ensure readiness for Data Base Lock as per planned dates. Ensure Closure of Sites as per defined process For Out-sourced trials: Provide efficient Sponsor oversight for trial Planning, Conduct, Closure, Quality Control and Payments and Budget controls. Ensure all Sponsor key deliverables (regulatory, recruitment, DBL, Quality, Operation and budget related) are met by CRO and advise management w.r.t foreseen risks and challenges. Plan mitigations and timely actions in collaboration with CRO team to avoid delays and potential risks. Ensure strong and effective communication maintained with CRO team. Train CRO staff as and when needed. Perform Co-monitoring activities and Quality checks periodically according to agreed plans and foreseen risks. Mentoring and Line Management of CRA’s/SR. CRA’s. Focus on Individual Development plans, provide timely feedback to team members on performance and improvement areas. Ensure effective delegation and allocations of tasks among team members. Ensure Goal settings, mid-year review and year end appraisals are completed for team member’s with-in timelines. Play an active roles in preparation and managing Site and Sponsor Audits Manage Investigator meeting planning and conduct prior to start of trial and during trial if needed.

Act as key member for Inspection readiness working groups.

Geographic Scope/ Market

India Cluster

Budget (if applicable)

Regional Clinical Operations Unit Budget

Work Conditions:

Full time

Physical Requirements:

Presence at work

Travel Estimate

Frequent

Education and Job Qualification

Minimum graduation in biological sciences and allied domains. Added qualifications will be preferred

Experience

Should have at-least > 10 years of experience in Clinical Operations years and at-least 2 years of experience in similar capacity with-in clinical project management.

  • Trial Capabilities Manager

    1 month ago

    gurugram, India Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. The Trial Capabilities Manager provides clinical trial capabilities in support of clinical development. The Manager is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing...

  • Trial Capabilities Manager

    1 month ago

    Gurugram, India Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. The Trial Capabilities Manager provides clinical trial capabilities in support of clinical development. The Manager is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing...

  • Trial Capabilities Manager

    3 weeks ago

    Gurugram, India Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. The Trial Capabilities Manager provides clinical trial capabilities in support of clinical development. The Manager is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing...

  • Trial Capabilities Manager

    3 weeks ago

    gurugram, India Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. The Trial Capabilities Manager provides clinical trial capabilities in support of clinical development. The Manager is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing...

  • Clinical Trial Coordinator

    3 weeks ago

    Gurugram, Haryana, India MSD Full time

    **Clinical Trial Coordinator**: Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as...

  • Clinical Trial Associate

    3 weeks ago

    Gurugram, Haryana, India ARIAD Full time

    **Clinical Trial Associate**: Gurgaon, Haryana **Job ID** R0120735 **Category** Research & Development **Subcategory** Research & Development **Business Unit** Global Portfolio Division **Job Type** Full time **OBJECTIVES**: - _Perform day-to-day management of CTMS and eTMF, including oversight of the review and approval of eTMF documents and...

  • Clinical Trial Associate

    3 weeks ago

    Gurugram, Haryana, India Takeda Pharmaceutical Full time

    **OBJECTIVES**: - _Perform day-to-day management of CTMS and eTMF, including oversight of the review and approval of eTMF documents and generation of reports to measure completeness, accuracy, and timeliness of the eTMF, as per applicable regulations and guidelines, and Takeda requirements_ **ACCOUNTABILITIES**: - _Lead the development of the study...

  • CRP (Franchise Medical Lead) - Obesity / Diabetes

    4 weeks ago

    Gurugram, India Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Purpose of the Role: Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Clinical Research Physician (CRP) is an integral member of the medical affairs, development and a business unit brand...

  • CRP (Franchise Medical Lead) - Obesity / Diabetes

    4 weeks ago

    gurugram, India Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Purpose of the Role: Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Clinical Research Physician (CRP) is an integral member of the medical affairs, development and a business unit brand...

  • Lead Insecticides

    1 month ago

    Gurugram, India PI Industries Full time

    Position Purpose The role holder is responsible for developing Insecticide Biology Plan with clear technical objectives. Responsible for timely and accurate compilation of in house and institutional trials for shortlisted molecules for insecticides with science based approach, including analysis, interpretations and summary preparation, draw right...

  • Lead Insecticides

    1 month ago

    gurugram, India PI Industries Full time

    Position Purpose The role holder is responsible for developing Insecticide Biology Plan with clear technical objectives. Responsible for timely and accurate compilation of in house and institutional trials for shortlisted molecules for insecticides with science based approach, including analysis, interpretations and summary preparation, draw...

  • Regional Sales Manager

    3 weeks ago

    Gurugram, India NAT HABIT Full time

    At 'Nat Habit' we are attempting to disrupt the natural personal care space by providing customers a differentiated offering of "fresh" personal care products. We use fresh ingredients such as milk, yogurt, pulp/juices of various fruits & vegetables as well as fresh flowers and leaves to build personal care products for everyday use. The founding team has a...

  • Regional Sales Manager

    3 weeks ago

    Gurugram, India NAT HABIT Full time

    At 'Nat Habit' we are attempting to disrupt the natural personal care space by providing customers a differentiated offering of "fresh" personal care products. We use fresh ingredients such as milk, yogurt, pulp/juices of various fruits & vegetables as well as fresh flowers and leaves to build personal care products for everyday use.The founding team has a...

  • Regional Sales Manager

    1 month ago

    Gurugram, India NAT HABIT Full time

    At 'Nat Habit' we are attempting to disrupt the natural personal care space by providing customers a differentiated offering of "fresh" personal care products. We use fresh ingredients such as milk, yogurt, pulp/juices of various fruits & vegetables as well as fresh flowers and leaves to build personal care products for everyday use.The founding team has a...

  • Regional Sales Manager

    1 month ago

    Gurugram, India NAT HABIT Full time

    At 'Nat Habit' we are attempting to disrupt the natural personal care space by providing customers a differentiated offering of "fresh" personal care products. We use fresh ingredients such as milk, yogurt, pulp/juices of various fruits & vegetables as well as fresh flowers and leaves to build personal care products for everyday use.The founding team has a...

  • Regional Sales Manager

    3 weeks ago

    Gurugram, India NAT HABIT Full time

    At 'Nat Habit' we are attempting to disrupt the natural personal care space by providing customers a differentiated offering of "fresh" personal care products. We use fresh ingredients such as milk, yogurt, pulp/juices of various fruits & vegetables as well as fresh flowers and leaves to build personal care products for everyday use.The founding team has a...

  • Regional Sales Manager

    1 month ago

    gurugram, India NAT HABIT Full time

    At 'Nat Habit' we are attempting to disrupt the natural personal care space by providing customers a differentiated offering of "fresh" personal care products. We use fresh ingredients such as milk, yogurt, pulp/juices of various fruits & vegetables as well as fresh flowers and leaves to build personal care products for everyday use. The founding team has a...

  • Practice Operations Sr. Associate 1

    1 month ago

    Gurugram, India RSM Full time

    We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. Our exceptional people are the key to our unrivaled, inclusive culture and talent experience and our ability to be compelling to our clients....

  • Practice Operations Sr. Associate 1

    1 month ago

    gurugram, India RSM Full time

    We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. Our exceptional people are the key to our unrivaled, inclusive culture and talent experience and our ability to be compelling to our clients....

  • Practice Operations Sr. Associate 1

    3 weeks ago

    Gurugram, India RSM Full time

    We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. Our exceptional people are the key to our unrivaled, inclusive culture and talent experience and our ability to be compelling to our clients....