Hiring company: Merck
Job Description
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
Under the direction of the applicable management, the Clinical Data Manager (CDM) 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 company Standard 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 entered 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 (Senior Clinical Data Manager) /LCDM (Lead Clinical Data Manager)
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 cycle-time 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:
H.S Diploma, or equivalent required
College coursework or start of degree preferred.
Knowledge and Skills:
Self-motivated, excellent in work planning and time management.
Fluent oral and written English skills.
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., 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.
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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 another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Work WeekShift:
1st - DayValid Driving License:
NoHazardous Material(s):
Number of Openings:
1