• Job Description

  Req#: R279231

  Job Description

  Position Overview:

  Under the direction of the applicable management, the Global Data Operations (GDO) Manual Encoding Lead (ME Lead) is responsible for executing end to end data management activities pertaining to the encoding of clinical trial data, including but not limited to: data management 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. Works with management to maintain the consistent execution of quality global procedures and monitors workload and resource allocation. Supports the comprehensive development of junior staff and encourages effective interaction of GDO staff with business partners to achieve common objectives. Is accountable for the quality and timely execution and delivery of GDO deliverables related to encoding at the trial and program level.

  Primary activities include, but are not limited to:

  • All activities of an Encoder.

  • Accountable for all encoding related protocol level start-up, in-life and database lock tasks and activities performed by all coding staff at the trial level.

  • Interact and communicate with customers and stakeholders both internal and external to GDMS as well as our company when needed.

  • Accountable within GDO to design, create, validate, review, approve and maintain encoding specifications as needed.

  • Coordinate the execution of user acceptance testing of encoding as needed.

  • Participate in relevant operational meetings.

  • Execute and trigger communications and escalations at the protocol level within department, within function and cross-functionally.

  • Execute and maintain adherence to a metrics control plan and quality assessment indicators at the trial level.

  • Coordinate the database lock activities related to encoding and triage and track issues to resolution.

  • Accept and execute special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/ or other special activities, such as developing and delivering programs and materials to instruct staff regarding business processes, leading or participating in cross functional technical improvement projects, etc.

  • Continually monitor for opportunities to improve efficiency, effectiveness and quality and implement changes as appropriate at the trial level, program level, TA level and GDO Level.

  • Performs tasks with minimal guidance from manager(s).

  • Serve as subject matter expert for encoding processes, globally and locally, at the trial level, program level and TA Level.

  Education and Experience (ex-Us subject to local requirements):

  • B.A. or B.S. degree, (preferably in Pharmacy, Nursing, Biological Sciences) with at least 3 years’ professional experience in clinical encoding or clinical data management

  OR

  • LPN, RN or equivalent with 5 years experience in clinical encoding or clinical data management

  OR

  • Associates Degree (preferably in Pharmacy, Nursing, Biological Sciences) with at least 5 years’ professional experience in clinical encoding or clinical data management

  OR

  • High School Diploma (or equivalent) with at least 6 years’ professional experience in clinical encoding or clinical data management.

  Required Knowledge and Skills:

  • Excellent communication skills (oral and written) with the ability to communicate with both the technical and business areas.

  • Knowledge of regulations and policies applicable to the pharmaceutical industry encoding.

  • Proficient overall working knowledge of the clinical development process and the value of encoding.

  • Excellent working knowledge of clinical practice and medical terminology.

  • Ability to work cross-functionally and as part of a team.

  • Ability to work under pressure in a changing environment with flexibility.

  • Ability to work independently and accept and act with appropriate accountability with minimal guidance by a manager.

  • Ability to coordinate the work of others and influence decision making.

  • Exceptional organizational, problem-solving and negotiating skills.

  Preferred Experience and Skills:

  • Excellent project management and leadership skills.

  • Experience with processes assessment and documentation updates.

  • Previous experience with MedDRA and/or WHODrug coding.

  #ONEGDMS

  #eligibleforERP

  #MRLGCTO

  #MSJR

  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 separationpackage, 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

  Current Contingent Workers apply HERE

  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 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

  EEOC GINA Supplement

  Pay Transparency Nondiscrimination

  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

  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:

  $111,400.00 - $175,300.00

  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.

  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:

  10%

  Flexible Work Arrangements:

  Hybrid, Remote Work

  Shift:

  Not Indicated

  Valid Driving License:

  No

  Hazardous Material(s):

  n/a

• About the company

  Merck & Co., Inc.,

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