Clinical Trial Coordinator

1 week ago

Gurgaon, Haryana, India MSD Full time

Job Description

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)

o Ensure collation and distribution of study tools and documents

o Update clinical trial databases (CTMS) and trackers

o Clinical supply & non-clinical supply management, in collaboration with other country roles

o Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)


• Document management:

o Prepare documents and correspondence

o Collate, distribute/ship, and archive clinical documents, e.g. eTMF

o Assist with eTMF reconciliation

o Execute eTMF Quality Control Plan

o Update manuals/documents (e.g., patient diaries, instructions)

o Document proper destruction of clinical supplies.

o Prepare Investigator trial file binders

o Obtain translations of documents


• Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:

o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions

o Obtain, track and update study insurance certificates

o Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.

o Publish study results for GCTO and RA where required per local legislation


• Budgeting, Agreement and Payments:

Collaborate with finance/budgeting representatives for:

o Develop, control, update and close-out country and site budgets (including Split site budget)

o Develop, negotiate, approve and maintain contracts (e.g. CTRAs)

o Track and report contract negotiations

o Update and maintain contract templates (in cooperation with Legal Department)

o Calculate and execute payments (to investigators, vendors, grants)

o Ensure adherence to financial and compliance procedures

o Monitor and track adherence and disclosures

o Maintain tracking tools

o Obtain and process FCPA documentation in a timely manner


• Meeting Planning:

o Organize meetings (create & track study memos/letters/protocols)

o 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


• Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.


• 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 of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/22/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:06/22/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R295065

  • Trial Capabilities Manager

    1 week ago

    Gurgaon, Haryana, 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 activities...

  • Global Trial Manager

    1 week ago

    Gurgaon, Haryana, 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...

  • Medical Writer Ii

    7 days ago

    Gurgaon, Haryana, India Syneos Health Clinical Full time

    DescriptionMedical Writer II (Clinical Trial Transparency & Redaction):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...

  • Principal Clinical Study Manager

    1 week ago

    Gurgaon, Haryana, India Haleon Full time

    Job Purpose: Principal Clinical Study Manager is at the heart of our Evidence Generation activities and aligned to our Cultural pillars of Go Beyond, Do What Matters Most and Keep it Human. The role provides operational leadership to the Clinical Study Team and is responsible for the planning, management, execution, and delivery of the trial according...

  • Central Report Reviewer

    1 week ago

    Gurgaon, Haryana, India Syneos Health Clinical Full time

    DescriptionCentral Report ReviewerSyneos 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 to the center of...

  • Manager-1-clinical Quality

    7 days ago

    Gurgaon, 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 LtdJob PurposeThe 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...

  • Associate Clinical Research Monitor

    1 week ago

    Gurgaon, Haryana, India Medtronic Full time

    Position Description:Responsibilities may include the following and other duties may be assigned. Monitors progress of clinical trials at the site level or headquarters and ensures that they are conducted, recorded andreported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and otherapplicable regulatory...

  • Senior Clinical Data Specialist

    1 week ago

    Gurgaon, Haryana, 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 awards...

  • Medical Writer Ii

    7 days ago

    Gurgaon, Haryana, India Syneos Health Clinical Full time

    DescriptionMedical Writer IISyneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve...

  • Medical Writer I

    1 week ago

    Gurgaon, Haryana, India Syneos Health Clinical Full time

    DescriptionMedical Writer ISyneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve...

  • Clinical Supervisor

    1 week ago

    Gurgaon, Haryana, India LifeWorks Full time

    Build a meaningful careerAt LifeWorks, we offer more than career opportunities, we provide career opportunities to make meaningful contributions to people's lives. The extraordinary expertise of a more than 7,000-strong workforce is harnessed to support the employees and families of the organizations we serve. Our innovative programs have a lasting impact on...

  • Principal Medical Writer

    1 week ago

    Gurgaon, Haryana, India Syneos Health Clinical Full time

    DescriptionPrincipal Medical WriterSyneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers...

  • Principal Biostatistician

    7 days ago

    Gurgaon, Haryana, India Syneos Health Clinical Full time

    DescriptionSyneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.Our...

  • Senior Executive

    1 week ago

    Gurgaon, Haryana, India SUN PHARMA Full time

    Job Summary The job holder shall be responsible for assuming the role of regulatory operation for the assigned branded programs (NCE/BLAs/other specialty products) who shall be responsible for all regulatory operations activities to include submission management, coordination, publishing (US, Canada, AU and other markets), document management, labeling...

  • Clinical Trial Associate

    7 days ago

    Gurgaon, Haryana, India Takeda Full time

    DescriptionOBJECTIVES:ACCOUNTABILITIES:EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:TRAVEL REQUIREMENTS:LocationsIND - GurgaonWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

  • Antara Senior Care

    1 week ago

    Gurgaon, Haryana, India Antara Assisted Care Services Limited Full time

    Role Summary: As a Clinical Affairs Specialist for D2C Healthcare New Products at AGEasy by Antara, you will play a critical role in leading the planning, execution, and management of clinical studies and trials for our directtoconsumer healthcare products. Your responsibilities will include developing and implementing clinical research strategies,...

  • Associate Director

    1 month ago

    Gurgaon, Haryana, India MSD Full time

    Job DescriptionAssociate Director - Clinical Research:This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.The CRM...

  • Associate Director

    3 weeks ago

    Gurgaon, Haryana, India MSD Full time

    Job DescriptionAssociate Director - Clinical Research:This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.The CRM...

  • Medical Writer I

    1 week ago

    Gurgaon, Haryana, India Syneos Health Clinical Full time

    DescriptionMedical Writer ISyneos 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 to the center of...

  • Country Call Center Operator

    1 week ago

    Gurgaon, Haryana, India Amplifon Full time

    Country Call Center Operator Gurgaon, Haryana, India Position & Grade CRE (English & Hindi (Mandatory) + Any South Language ) Experience Required At least 2 years + with 1 year minimum in Outbound Location Gurgaon Reporting to Team Leader Job Purpose: Calling fresh leads & follow up clients and make sure the desired number of visits of the...