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Senior Technical Project Manager (Clinical Research)

Company: Merck
Location: Rahway
Posted on: November 11, 2019

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 Senior Technical Project Manager is responsible 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, collaborates 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. Education_Minimum_Requirement * B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline. Required_Experience_And_Skills * A minimum of 6 years of experience in Clinical Data Management (or related discipline) for technology acquisition and implementation. * A minimum of 3 years of experience working with formal project management tools and processes. * In-depth knowledge of the clinical development process, preferably through submission. * Thorough knowledge of clinical data management; demonstrated knowledge of technical processes inclusive of electronic Case Report Form (eCRF) development, clinical database development, data validation tool development, user acceptance testing, data integration from different sources, data flow/migration, and application of CDASH and SDTM standards. * 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. Preferred_Experience_And_Skills * Experience in assessing, developing, and/or implementing new technology capabilities preferred. We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science and that great medicine make a significant impact to our world. And 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. Merck & Co., Inc., Kenilworth, New Jersey, USA is known as Merck in 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. If you need an accommodation for the application process please email us at *********************** 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 No Travel Required Shift Flexible Work Arrangements: Hazardous_Material(s) Valid Driving License: Number_Of_Openings 1 Requisition ID:R19141

Keywords: Merck, New York , Senior Technical Project Manager (Clinical Research), IT / Software / Systems , Rahway, New York

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