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 applicable.

The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.

**Responsibilities include, but are not limited to**:

- Trial and site administration: o Track (e.g. essential documents) and report (e.g. Safety Reports)
- Ensure collation and distribution of study tools and documents
- Update clinical trial databases (CTMS) and trackers
- Clinical supply & non-clinical supply management, in collaboration with other country roles
- Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)
- Document management:

- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents, e.g. eTMF
- Assist with eTMF reconciliation
- Execute eTMF Quality Control Plan
- Update manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
- Obtain translations of documents
- Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:

- In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
- Obtain, track and update study insurance certificates
- Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
- Publish study results for GCTO and RA where required per local legislation
- Budgeting, Agreement and Payments:
Collaborate with finance/budgeting representatives for:

- Develop, control, update and close-out country and site budgets (including Split site budget)
- Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
- Track and report contract negotiations
- Update and maintain contract templates (in cooperation with Legal Department)
- Calculate and execute payments (to investigators, vendors, grants)
- Ensure adherence to financial and compliance procedures
- Monitor and track adherence and disclosures
- Maintain tracking tools
- Obtain and process FCPA documentation in a timely manner
- Meeting Planning:

- Organize meetings (create & track study memos/letters/protocols)
- Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

**Skills**:

- Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices
- ICH-GCP Knowledge appropriate to role
- Excellent negotiation skills for CTCs in finance area
- Effective time management, organizational and interpersonal skills, conflict management
- Effective communication with external customers (e.g. sites and investigators)
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus, both internally and externally.
- Able to work independently
- Proactive attitude to solving problems / proposing solutions
- Positive mindset, growth mindset

**Qualification & Experience**:

- Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree

**Who we are**

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for**

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases o

  • Trial Capabilities

    5 days ago

    Gurugram, Haryana, India HCAH Full time

    Clinical Trial Responsibilities - Assist investigator site activation activities, including compilation and submission/notification of regulatory documents. - Assisting Trial Capabilities Associate on study document management & tracking for IRB/IEC submissions throughout the study. - Track site compliance to required training to effectively drive timelines...

  • 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...

  • 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...

  • Global Trial Manager

    3 weeks ago

    Gurugram, India SUN PHARMA Full time

    Responsibilities : Oversight of CRO / other vendors and study management- Oversees CRO pre-site selection and site initiation, interim close-out and co-monitoring visits to ensure compliance with protocol and regulatory requirements and to assure good site performance Assists in the management of CROs and other vendors to ensure project requirements...

  • Global Trial Manager

    3 weeks ago

    gurugram, India SUN PHARMA Full time

    Responsibilities : Oversight of CRO / other vendors and study management- Oversees CRO pre-site selection and site initiation, interim close-out and co-monitoring visits to ensure compliance with protocol and regulatory requirements and to assure good site performance Assists in the management of CROs and other vendors to ensure project...

  • Central Report Reviewer

    2 weeks ago

    Gurugram, Haryana, India Syneos Health Clinical Full time

    **Description** **Central Report Reviewer** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...

  • 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...

  • Manager-1-clinical Quality

    2 months ago

    Gurugram, Haryana, India Sun Pharmaceutical Industries Ltd Full time

    **Title**:Manager-1-Clinical Quality & Process**: - Date: May 3, 2024- Location: Gurgaon - R&D- Company: Sun Pharmaceutical Industries Ltd**Job Purpose** The Clinical Process and Quality Manager (CPQM) is primarily responsible to support all Global Development (GD) functions for ensuring audits and inspection readiness through periodic quality control...

  • Manager-1-clinical Quality

    2 months ago

    Gurugram, Haryana, India Sun Pharmaceutical Industries Ltd Full time

    **Job Purpose** The Clinical Process and Quality Manager (CPQM) is primarily responsible to support all Global Development (GD) functions for ensuring audits and inspection readiness through periodic quality control activities. **Key Roles and Responsibilities** - Acts as Quality Partner for assigned Global Development Functions and drives Quality...

  • Clinical and Patient Care Coordinator

    7 days ago

    Gurugram, Haryana, India CIFAR HEALTHCARE PVT. LTD. Full time

    **Job/Position Summary**: This is a full-time on-site role as Clinical and patient care Coordinator. A Clinical and patient care Coordinator will play a crucial role in assisting patients through the infertility journey at CIFAR. He/ She will work closely with patients, doctors, and other healthcare professionals to ensure a seamless and compassionate...

  • Clinic Coordinator

    1 month ago

    Gurugram, India Aspen Dental Full time

    Company Description Aspen Dental is a premier dental clinic located in Gurugram, offering comprehensive dental care services. Our team of smile architects is renowned for their gentle care, unwavering dedication, and cutting-edge technology. With a focus on personalized attention and a tranquil environment, we strive to uplift spirits and create signature...

  • Clinic Coordinator

    1 month ago

    Gurugram, India Aspen Dental Full time

    Company Description Aspen Dental is a premier dental clinic located in Gurugram, offering comprehensive dental care services. Our team of smile architects is renowned for their gentle care, unwavering dedication, and cutting-edge technology. With a focus on personalized attention and a tranquil environment, we strive to uplift spirits and create signature...

  • Clinic Coordinator

    1 month ago

    gurugram, India Aspen Dental Full time

    Company DescriptionAspen Dental is a premier dental clinic located in Gurugram, offering comprehensive dental care services. Our team of smile architects is renowned for their gentle care, unwavering dedication, and cutting-edge technology. With a focus on personalized attention and a tranquil environment, we strive to uplift spirits and create signature...

  • Research Associate

    2 months ago

    Gurugram, Haryana, India medONE Pharma Solutions Full time

    We are currently looking for passionate, and committed professional to join our team as Research associates. B. Pharm, M. Pharm with work experience and/or Post Graduate Diploma in clinical research, preferred. The ideal profile will have 0.5- 2 years of experience. An equivalent combination of education, training and experience may be accepted in place of a...

  • Research Associate

    2 months ago

    Gurugram, Haryana, India medONE Pharma Solutions Full time

    We are currently looking for passionate, and committed professional to join our team as Research associates. B. Pharm, M. Pharm preferred or Bachelor's Degree in a Life Sciences discipline or health care, with Post Graduate Diploma in clinical research. The ideal profile will have 0.5- 2 years of experience. An equivalent combination of education, training...

  • Staff Engineer Clinical Affairs

    2 weeks ago

    gurugram, India Stryker Full time

    Why join Stryker? We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting Our total rewards package offering includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance...