Specialist, Clinical Data Management Job

Employer
Merck
Location
West Point, PA, US
Posted
June 20 2017
Discipline
Other
Organization Type
Pharma
Specialist, Clinical Data Management-CLI006073

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

The Interactive Response Technology (IRT) & Clinical Outcomes Assessment (COA)Specialist is responsible for providing end-to-end IRT & COA systems project management support including, but not limited to, gathering study-specific user requirements, may execute UAT tasks, managing project timelines, managing and enforcing IRT & COA systems Standards. IRT & COA Specialist also monitors system change requests and acts as Merck’s IRT & COA systems subject matter expert while liaising with external vendors.

Applies IRT & COA systems expertise on day-to-day activities when issues are escalated. Communicates with internal and external stakeholders and escalates risks. May participate in process improvement initiatives, standards development and maintenance.

Primary Activities

1. Provides support for execution of IRT & COA systems development process from Kickoff to system go live, ongoing system change control, system closeout and database lock activities.
2. Provides support for the creation and use of IRT & COA systems standards. Responsibilities may include creation / revision of IRT & COA systems standards, collaboration with vendors and internal stakeholders to define requirements, and monitoring standards utilization.
3. Serves as project manager of all IRT & COA systems activities for protocols assigned. Uses interpersonal, negotiating, and project management skills to perform the following tasks:

- Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all IRT & COA systems related issues and end of study vendor deliverables
- Activity definition and sequencing, duration estimation, schedule development, and schedule control.
- Risk management planning (i.e., risk identification, analysis, and response planning, as well as risk monitoring and control).
- Communication planning, information distribution, performance reporting, and project closure.
4. Obtains internal and external stakeholder feedback; this may include meeting with vendor project managers and/or meeting with subject matter experts or representatives from stakeholder functional areas.
5. Provides support for successful integration of Merck and vendor systems.
6. Provides support for problem resolution between IRT & COA systems vendors and Merck Clinical Trial Team.
7. May assist in development of, reference and/or training material.
8. May support a continuous improvement special project or any other project or perform any other IRT & COA systems related task deemed appropriate by management

Qualifications

Education:

- B.A. or B.S. degree, preferably in life sciences, computer science, engineering or related discipline.

Required:

- 4 years’ experience in Clinical Data Management with at least 2 years’ of IRT Systems and/or COA working experience
- Demonstrate knowledge of IRT & COA systems development processes
- Knowledge of the clinical development process, preferably through submission; thorough knowledge of clinical data management
- Solid experiences in study start up activities for EDC Inform/ IRT Systems/ COA (paper & e)
- Demonstrated project management skills; strong organizational, communication, and problem-solving skills.
- Experience working with external vendors

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Clinical Data Management

Job Title:Spclst, Clinical Data Mgmt

Primary Location: NA-US-PA-West Point

Other Locations: NA-US-NJ-Rahway

Employee Status: Regular

Number of Openings: 1

Shift (if applicable): N/A

Company Trade Name:Merck