Job Description

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.

Primary Responsibilities:

* Assumes the responsibilities for programming all reporting deliverables needed for data cleaning and verification including InForm studies and the external data captured in support of the clinical studies.

* May support special request reports with greater complexity for decision making.

Coordinates and participates in the following activities:

20% Oversees and coordinates data reporting activities for multiple clinical programs.

* Interfaces with RaM Manager to assure consistency of technical and process strategies.

* Acts as a technical resource to other members of the group.

* Plans appropriately to ensure adherence to timelines.

* Consults with spec authors/study teams and key stakeholders to provide technical clarifications for the development of report specifications.

40% Creates and develops reporting programs to meet SDTM structure requirements and data cleaning/review needs to ensure quality and availability of reports in support of data review/cleaning activities.

* Perform QC activities as needed.

* Ensures adherence to clinical database standards, SOPs, and Process Guidelines.

* Leads and/or participates in the review of trial level eCRFs, standard and template reports, and scripts to aid in the review of data to ensure a quality database in support of Analysis and Reporting performed by Scientific Programming.

20% Trains new hires and may participate in the interview process.

* Provide ongoing training and development to RaM Report Developers on existing standards.

* Helps to develop a customer oriented and can-do attitude in the group and contributes as subject matter expert for trouble-shooting findings.

15% Leads and participates in extra activities including, but not limited to, task forces, testing of new systems and helps coordinate RaM technical initiatives.

* Contributes to development of strategies, innovative and creative solutions to enhance processes and increase productivity of the group.

* May provides support to other functions within department..

5% Assists RaM Manager/Associate Director in project planning, manpower projections and resource allocations across therapy areas.

* Interfaces with RaM Manager/Associate Director to assure consistency of technical and process strategies across all therapy areas.

Education Minimum Requirements:

* B.A. or B.S. degree, preferably in mathematics, science, a health care related discipline, or computer science.

Required Experience and Skills:

* 5+ yrs programming experience w/ PL-SQL, and SQL

* 3 yrs experience working with Clinical Data Mgmt Reporting Systems including Inform, JReview, DMW/LSH.

* 3+ yrs programming in SAS and MS Access database experience/DBA Skillset preferred (i.e Oracle Apex and like applications)

* Versed in System Development Lifecycle Mgmt/ system validation experience

* Excellent communication skills working with external customers and peer stakeholders

* Process oriented, multi-tasker with strong organizational and problem-solving skills

* Collaborative, customer focused, with solid time management skills

* Understanding of drug discovery and data validation, GXP, ICH guidelines, 21 CFR Part 11 guidelines

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 staffingaadar@msd.com
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:

10%

Flexible Work Arrangements:

Telecommuting

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

No

Number of Openings:

1
Requisition ID:R82666