Safety Data Manager

hace 2 semanas

San José, San José, Costa Rica MSD A tiempo completo

Job Description:


Under the direction of the applicable management, the Clinical Data Management Analyst is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with the companyStandard Operating Procedures (SOPs) and ICH-GCP guidelines.


Primary activities include, but are not limited to:

  • Receives the study related paper documents (i.e. patient diary, adjudication, etc.) from sites or other functional areas, registers them into a work management tool and transfers to data enterer for processing.
  • Performs Sponsor Data Entry as applicable per data management plans following entry guidelines.
  • Participates in the development and change request implementation of data management tools and systems for the clinical trial data management activities under the direction of the SCDM/LCDM
  • Runs data integrity check reports in accordance with data review plans and relevant SOPs.
  • Raises questions to investigational site staff and internal and external vendors, reviews responses and corresponding data corrections to confirm identified issue resolution.
  • Responsible for the execution of user acceptance testing of data management tools under the guidance of the SCDM/LCDM.
  • Escalates overdue items, including but not limited to outstanding questions and missing visits.
  • Assists the Senior/Lead CDM with data management activities to resolve all identified data issues prior to study database lock.
  • Complete trial level archiving activities under the direction of the SCDM/LCDM including, but not limited to, filing of essential documentation.
  • Maintains compliance with standard key performance indicators according to process expectations at the protocol level.
  • Monitors data quality and cycletime performance measures to maintain compliance, performs root cause analysis and implements action plans as needed.
  • Proactively communicates with Senior/Lead CDM to share project status, risk assessment and outstanding item resolution status.

Education:

  • At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care or data science related discipline.

Knowledge and Skills:

  • Fluent oral and written English skills
  • C1 level or above.
  • Advanced level of Excel.
  • Background in areas of data management, AI, Machine Learning or similar.
  • Selfmotivated, excellent in work planning and time management.
  • Good sense and awareness of regulations and policies.
  • Able to work under pressure and in a changing environment with flexibility.
  • Good communication skills with the ability to communicate with both the technical and business areas.
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., 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 workpla

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