Job Description

Job Description

Our Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

This role is responsible for comprehensive trial and site administration. Under the oversight of the Senior Clinical Operations Manager (COM) or COMs, the person prepares, collates, distributes, and archives clinical documents.

The Clinical Trial Coordinator (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 the Internal Review Board / Ethics Review Committee and Health Authorities. The role will collaborate at the local level closely with Clinical Operations Manager (COM), Clinical Research Manage (CRM) and Clinical Research Associate (CRA).

Responsibilities include, but are not limited to:

Trial and site administration:

* 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

Document management:

* Prepare documents and correspondence

* Collate, distribute/ship, and archive clinical documents, e.g. electronic Trial Master File (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

Institutional Review Board (IRB/ERC) and support regulatory agencies submissions.

* Publish study results for Global Clinical Trial Operations (GCTO) and Regulatory Authority (RA) were required per local legislation.

CORE Competency Expectations:

* 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.

* International Council for Harmonisation Good Clinical Practice (ICH-GCP) knowledge appropriate to role.

* Excellent negotiation skills for CTCs in finance area.

Behavioral Competency Expectations:

* 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 and proactive attitude to solving problems / proposing solutions.

Minimum Required Education and Experience:

* B.A./B.S. (Life Sciences/STEM preferred) graduating by June.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are

We are known as Merck & Co., Inc., Kenilworth, 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

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Residents of Colorado

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:

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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 anothers thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

Flexible Work Arrangements:

Remote Work

Shift:

Not Indicated

Valid Driving License:

Hazardous Material(s):

Number of Openings:

5
Requisition ID:R110339