Associate Clinical Operations Manager

hace 2 semanas

Bogotá, Bogotá D.E., Colombia MSD A tiempo completo

Job Description:

We are a research-driven biopharmaceutical company.

Our mission is built on the simple premise that if we "follow the science" and that great medicines can make a significant impact to our world.

And 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.


Associate Clinical Operations Manager
This role is responsible for comprehensive trial and site administration. Under the oversight of the Senior Clincal Operations Manager, the person prepares, collates, distributes and archives clinical documents.

The Associate Clinical Operations Manager 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 Institutional Reviwe Board/Ethics Review Committee (IRB/ERC) and Health Authorities.

The role will collaborate at local level closely with Clinical Operation Manager, Clinical Research Manager and Clinical Research Associate. And the person collaborates with finance/budgeting representatives to manage Clinical Trial Research Agreements and payments.

Responsibilities include, but are not limited to:

  • 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 & nonclinical supply management, in collaboration with other country roles
  • Manage Labeling requirements and coordinate/sign translation change request

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
  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) Knowledge appropriate to role
  • Excellent negotiation skills for Clinical Trials Coordinators in finance areas

Experience Requirements:

  • Minimum 23 years in Clinical Research or relevant healthcare experience

Educational Requirements:

  • Completed job training (office management, administration, finance, health carepreferred) or B.A./B.S.
    (Life Science preferred) or equivalent healthcare experience

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.

Search Firm Representatives Please Read Carefully

Employee Status:

Project Temps (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:
R224807

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