**Job Description**

Position Overview:

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 our company's 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) 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 Senior/Lead CDM (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 SCDM/LCDM 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 SCDM/LCDM to share project status, risk assessment and outstanding item resolution status.

**Education and Experience:**

+ a minimum of a high school diploma (or equivalent) required.

**Required experience and skills:**

+ Self-motivated, excellent in work planning, time management and multi-tasking.

+ 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.

**MSJR**

**\#EligibleforERP**

**MRLGCTO**

**\#ONEGDMS**

**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.

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.**

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

**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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

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.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

**U.S. Hybrid Work Model**

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$68,400.00 - $107,700.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .

**Search Firm Representatives Please Read Carefully**

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:**

No Travel Required

**Flexible Work Arrangements:**

Hybrid

**Shift:**

1st - Day

**Valid Driving License:**

No

**Hazardous Material(s):**

No

**Requisition ID:** R289813