Vacancy expired!
Job DescriptionOur 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 Senior Technical Project Manager is accountable for the oversight and management of the end-to-end delivery of technical data management components for one or more drug/vaccine programs. Provides technical consultation on the data management strategy, partners with appropriate functional areas to secure and align resources, and ensures all aspects of the technical project plan for in-scope studies are executed on time and with quality. Supports less experienced Technical PMs in the development of project plans which span from design and specification development through production deployment and subsequent change management support.Independently engages with cross-functional stakeholders to facilitate delivery of data management components based on knowledge of clinical database standards, technology, and program requirements. Serves as a program point of contact for any issues or concerns related to the development, maintenance, and consistency of technical components. Manages customer and stakeholder expectations. Represents Global Clinical Data Integration (GCDI) on cross-functional Global Data Management project teams.Participates in the development of, and ensures adherence to, Merck clinical data management procedures. Interacts with staff across multiple Merck sites and external vendors.Provides consultancy to ensure that data from disparate sources and database structures align with the overarching clinical data management strategy. Participates in the development of, and ensures adherence to, Merck clinical and regulatory data management standards.Able to work independently or as a team member or leader with equal effectiveness. Interacts with staff across multiple Merck sites and external vendors. Mentors, guides, and provides project leadership for junior staff as assigned.Primary Activities:Oversees the strategy and project plans for the development, testing and deployment of all technical deliverables (including, but not limited to, electronic Case Report Forms (eCRFs) data collector, edit checks, validation checks, IVRS integration, external data set-up and loading, Central Data Repository data flow).
Works independently with different functional groups to ensure appropriate resourcing and coordinate execution of technical deliverables.
Partners with functional area representatives to assess and promote program-level consistency in the use of database standards and program-level design.
Provides program-related oversight and guidance to Technical PMs and promotes quality and consistency in the use of database standards and deliverables across trials within a program.
5.Uses excellent interpersonal, negotiating, and project management skills to perform the following tasks:Project plan development, execution, and change control
Team facilitation and resource coordination
Risk management
Stakeholder management and communication including status reporting
Keeps abreast of project management, technology and clinical data management disciplines through interaction with experts.
Identifies and develops improvements to data collection and data management processes and tools. Supports audits and inspections as necessary.
May lead a continuous improvement / technical enabling special project, including, but not limited to, data management improvement task force, automations, testing of new systems, any other task deemed appropriate by management.
May serve as PM for one or more trials within assigned programs.
Education:B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.
Experience:At least 6 years’ experience in Clinical Data Management (or related discipline) for technology acquisition and implementation. At least 3 years’ experience working with formal project management tools and processes.
Knowledge and Skills:Knowledge of the clinical database development, data validation tool development, user acceptance testing, and data integration from different sources. Experience using project management tools such as Microsoft Project.
Demonstrated leadership and project management skills; strong organization, communication, negotiation, and problem-solving skills. Strong customer-focus and interacts effectively with different functional groups. Experience in assessing, developing, and/or implementing new technology capabilities preferred.
#EligibleforERPMRLGCTO#ONEGDMSWe 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.NOTICE 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.Residents of ColoradoClick here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.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.For more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)EEOC GINA SupplementOFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf)Pay Transparency NondiscriminationWe 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.Residents of Colorado:Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.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:Hazardous Material(s):NoNumber of Openings:1Requisition ID: R204922
Vacancy expired!