**Job Description**
Working closely with the Head of Global Clinical Data Standards (GCDS) within the Global Data Management & Standards (GDMS) organization, the Director of GCDS Delivery Management is accountable for the management and timely delivery of standards and governance related deliverables, within his/her defined scope, produced by GCDS.
The Director of GCDS Delivery Management is responsible for development, implementation, and oversight of the standards delivery framework and associated processes that drive end-to-end planning, delivery, and governance of GDMS standards components. The position is responsible for the management and supervision of GCDS personnel. The Delivery Manager is also responsible for developing, mentoring, and providing leadership to staff under supervision.
Serves as a member of the GCDS Leadership Team, and proactively engages with stakeholders inside and outside of GCDS to ensure standards and governance delivery in adherence to applicable processes, procedures, standards, and clinical program requirements.
**Education**
+ B.A. or B.S. degree, preferably in life sciences, information technology, or related discipline.
**Required Experience and Skills:**
+ Minimum of 10 years’ experience in Clinical Data Management (or related discipline)
+ Minimum of 5 years’ experience managing an organization responsible for data management delivery in a regulated environment (i.e., systems development, validation, implementation, change management)
+ Minimum of 5 years’ experience in direct-line people management
+ Experience managing clinical data management processes including electronic Case Report Form (eCRF) design, clinical database development and validation, user acceptance testing, external data management, data extraction, and reporting
+ Exceptional communication skills (oral and written), with the ability to communicate with both the technical and business functional areas
+ Exceptional people and thought leadership skills, with the ability to think strategically and to influence others.
+ Must have an innovative spirit, outstanding interpersonal skills, and demonstrated proficiency in the management of multiple projects.
**Preferred Experience and Skills:**
+ Knowledge of and direct experience implementing industry standards (e.g. Controlled Terminologies, CDISC CDASH, SDTM, ADaM, & HL7) and requirements for submission deliverables (e.g., SDRG, ADRG, Define.xml)
+ Strong leadership and proven ability to drive results in a global, matrix environment
+ Ability to effectively collaborate and problem solve across both business and technical functions
+ Experience applying formal project management tools and processes
+ Experience building and/or developing an organization
We 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. 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.
**US and Puerto Rico Residents Only:**
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 at https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEOC GINA Supplement at https://www.eeoc.gov/sites/default/files/migrated_files/employers/eeoc_gina_supplement.pdf
OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf
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:**
10%
**Flexible Work Arrangements:**
Flex Time, Remote Work
**Shift:**
Not Indicated
**Valid Driving License:**
**Hazardous Material(s):**
none
**Number of Openings:**
1
**Requisition ID:** R85208
