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Job DescriptionPosition Overview:In connection with other GDMS roles, the Study Designer (SD) role is accountable for:
ensuring quality and consistent E2E data management deliverables within and across trials within their assigned TA(s)
ensuring the appropriate cross-functional perspectives are incorporated into the trial design and change control processes.
The role is responsible to support Trial design, including new components and updates to existing Library components as per Protocol/Program design requirements and Industry Standards, as well as monitoring and supporting the ongoing change control of data management deliverables for the life of the trial as needed.The SD will interact with staff across multiple of our company's Functional Areas and serve in the role of guiding Study Teams in applying global standards and industry best practices into E2E study design.Primary activities include, but are not limited to:Accountable for Clinical Trial Study Design activities to ensure complete, comprehensive and high quality E2E design and deliverables.
Interact with cross functional study team resources (e.g. BARDS, Clinical, GDMS, External Vendors) to gather trial requirements (including new/updated components) and assure appropriate integration of all data sources.
Ensures quality and consistency of the E2E data management specifications within and across trials in a Program and/or Therapeutic Area (TA). This may include, but is not limited to:
Authoring data collection specifications for new and updated components
Including creation, submission and management of the Standards Request Package
Excluding COA & IRT Vendor Specs
Review and approval of Trial level data collection, handling and validation specifications, including data Integration and data reconciliation specifications.
Support change management (change requests), as applicable.
Author new data collection components or significant changes to data collection components
Review/approve adding additional existing data collection components.
Ensures appropriate use of Global, TA and Industry Standards at the Trial level.
Apply critical assessment, industry knowledge and expertise to make recommendations for efficient and effective data collection/design at Trial level, to optimize collection, validation, reconciliation and system setup while delivering the requirements to stakeholders and customers.
Identifies and develops areas for improvement in data management processes, standards and tools.
May lead continuous improvement special projects, or any other data management tasks deemed appropriate by management.
Participates in the Standards Review Committee and/or Therapy Area Standards Teams (TAST) as appropriate.
Mentor and train staff as needed.
Minimum education required:B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline AND 5 years’ experience in Clinical Data Management in the Pharmaceutical industry. OR 10 Years' experience in End to End Clinical Data Management Trial Design, Build and Execution.Required experience and skills:
Knowledge of the clinical development process, on the therapy area of interest and on how to translate Protocol requirements into data management specifications
Expert knowledge of end to end clinical data management and the impact to downstream consumers
Excellent analytical and creative problem solving, critical thinking, conflict resolution, communication, organizational, and multi-tasking skills
Innovative mindset
Strong understanding of CDISC/Study Data Tabulation Model (SDTM) and corresponding implementation guides, CDISC terminologies and the related regulations for submission deliverables
Process oriented with Quality Assurance/Quality Control prior experience.
Ability to work under pressure in a changing environment.
Understanding of data management systems and tools and their interactions
Demonstrated leadership and collaboration skills to establish good working relationship within internal teams and external stakeholders
Ability to be flexible and work independently.
Open to new learning opportunities to improve the way we work.
#EligibleforERP#ONEGDMSNOTICE FOR INTERNAL APPLICANTSIn 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/inst/1422$1533/rel-task/3001$14.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/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA SupplementPay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.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 ModelEffective 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:$135,500.00 - $213,400.00Available 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 CarefullyMerck & 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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License:NoHazardous Material(s):n/aRequisition ID: R276381
Vacancy caducado!