Clinical Data Management - Associate Trial Manager

Merck & Co., Inc. West Point , PA 19486

Posted 2 months ago

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.

The Associate Trial Manager assists in ensuring the successful execution of the clinical trial data management strategy for assigned trials within a specific drug/vaccine program. Assists in start-up activities, database maintenance, and database finalization for each trial. Attends Study Team meetings and works in a team environment. Assists in developing and managing project plans which span from protocol development through database lock. Ensures all aspects of the project plan are executed on time and with appropriate quality.

Under the guidance/supervision of more senior staff assumes the following responsibilities:

Develops detailed project plans for the collection, review, and cleaning of all clinical data for assigned trials within a specific drug/vaccine program. Data includes, but is not limited to; case report form (CRF) data, lab data, biomarker data, and patient reported outcomes.

Supports the project management of all clinical data management activities with incremental responsibilities for trials as assigned, using excellent interpersonal, negotiation, and project management skills to assist with the following tasks:

  • Project planning, initiation, execution, change control, and closing.

  • Risk management identification.

  • Meeting customer/stakeholder expectations.

Meets trial-level requirements for quality data collection and validation at the trial level.

  • Reads and interprets the clinical protocol from a clinical data management perspective.

  • Provides clinical data management input into trial design, as appropriate, ensuring operational feasibility.

  • Ensures appropriate use of standards and project-level consistency of database design, data collection, and validation.

  • Facilitates assessment and assists in processing of standards and change requests.

Participates and manages trial-level data quality and completion of database lock and post-database lock activities:

  • Monitors overall status and quality of data being collected during the in-life portion of a trial.

  • Ensures activities required to achieve database lock (or data extraction) are completed by appropriate, responsible functional area.

  • Ensures timely archival of trial data and documentation.

  • Ensures timely decommissioning of clinical data management technologies.

Education Minimum Requirements:

  • B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.
Required Experience and Skills:
  • At least 2+ years' experience in data management, medical research, or database design and development additional experience in project management tools and process would be beneficial.

  • Good basic awareness of the clinical research development process.

  • Familiar with database concepts and tools.

  • Proven leadership skills, specifically the ability to coordinate the work of others.

  • Good sense and awareness of regulations and policies.

  • Must be able to communicate effectively - orally and in written form - with other stakeholders.

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

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

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:

10%

Flexible Work Arrangements:

Remote Work, Telecommuting

Shift:

1st

  • Day

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1

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VIEW JOBS 10/9/2020 12:00:00 AM 2021-01-07T00:00 Job Description The Associate Trial Manager assists in ensuring the successful execution of the clinical trial data management strategy for assigned trials within a specific drug/vaccine program. Assists in start-up activities, database maintenance, and database finalization for each trial. Attends Study Team meetings and works in a team environment. Assists in developing and managing project plans which span from protocol development through database lock. Ensures all aspects of the project plan are executed on time and with appropriate quality. Under the guidance/supervision of more senior staff assumes the following tasks: * Develops detailed project plans for the collection, review, and cleaning of all clinical data for assigned trials within a specific drug/vaccine program. Data includes, but is not limited to; case report form (CRF) data, lab data, biomarker data, and patient reported outcomes. * Supports the project management of all clinical data management activities with incremental responsibilities for trials as assigned, using excellent interpersonal, negotiation, and project management skills to assist with the following tasks: * Project planning, initiation, execution, change control, and closing. * Risk management identification. * Meeting customer/stakeholder expectations. * Meets trial-level requirements for quality data collection and validation at the trial level. * Reads and interprets the clinical protocol from a clinical data management perspective. * Provides clinical data management input into trial design, as appropriate, ensuring operational feasibility. * Ensures appropriate use of standards and project-level consistency of database design, data collection, and validation. * Facilitates assessment and assists in processing of standards and change requests. * Participates and manages trial-level data quality and completion of database lock and post-database lock activities: * Monitors overall status and quality of data being collected during the in-life portion of a trial. * Ensures activities necessary to achieve database lock (or data extraction) are completed by appropriate functional area. * Ensures timely archival of trial data and documentation. * Ensures timely decommissioning of clinical data management technologies Education: * B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline. 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Who we are … Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development. 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. US and Puerto Rico Residents Only: If you need an accommodation for the application process please email us at staffingaadar@msd.com For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement OFCCP Pay Transparency Rule We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations. 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: 10% Flexible Work Arrangements: Remote Work Shift: 1st - Day Valid Driving License: Hazardous Material(s): Number of Openings: 1 Merck & Co., Inc. West Point PA

Clinical Data Management - Associate Trial Manager

Merck & Co., Inc.