2018 MRL PDMS Trial Manager Intern Job

Employer
Merck
Location
Rahway, NJ, US
Posted
August 30 2017
Discipline
Other
Organization Type
Pharma
2018 MRL PDMS Trial Manager Intern:ADM008625

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.

This summer intern position will oversee the data management strategy and project plans for collection and integration of all clinical data including but not limited to case report forms (CRF) data, lab data, biomarker data, and patient reported outcomes for one or more trials within a specific drug program. The intern will work with a cross-functional team across multiple sites to ensure that all aspects of the project plan (from protocol planning through data management submission components) are executed on time and with appropriate quality. In addition, this role serves as project manager of all clinical data management activities for trials as assigned.

Under the guidance of more senior staff when appropriate, the intern will use excellent interpersonal, negotiating, and project management skills to perform and manage the following tasks:

- Project planning, initiation, execution, change control, and closing.

- Project team development, project team leadership, meeting management, and resource coordination.

- Risk management planning (i.e., risk identification, analysis, response planning, monitoring, and control), including escalation as necessary.

- Management of customer / stakeholder expectations; facilitation of cross-functional decisions.

- Define trial-level requirements for quality data collection and validation at the trial level.

- Read and interpret the clinical protocol from a clinical data management perspective.

- Provide clinical data management input into trial design, as appropriate, ensuring operational feasibility.

- Engage with key stakeholders and subject matter experts to assess complexity, define trial-level data management requirements and inputs (including timing), and confirm all data management deliverables and services required for a trial.

- Ensure appropriate use of standards and project-level consistency of database design, data collection, and validation.

- Facilitate assessment and processing of standards and change requests.

- Manage trial-level data quality and completion of database lock and post-database lock activities:

- Monitor overall status and quality of data being collected during the in-life portion of a trial.

- Engage with key stakeholders and subject matter experts to refine data management tools and validation plans, as appropriate.

- Ensure activities required to achieve database lock (or data extraction) are completed by appropriate, responsible functional area.

- Ensure timely archival of trial data and documentation.

- Ensure timely decomissioning of clinical data management technologies.

Qualifications

Education:

- Required: Current student pursuing a BA/BS degree in a life sciences discipline, computer science, or science related field.

Required Experience:

- Must have interest in data and project management

- Strong proficiency in Microsoft Office

- Familiarity with Microsoft Project

Preferred Experience:

- Understanding of the clinical research process and some basic Clinical Data Management lifecycle knowledge

- Familiar and comfortable with database concepts and tools to manage, extract, and report clinical data

- Strong organization and management skills

- Ability to communicate effectively both orally and in written form with technical and business areas.

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.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

FTP2018



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


Primary Location: NA-US-NJ-Rahway

Other Locations: NA-US-PA-West Point

Job Type: Intern

Employee Status: Temporary

Travel: No

Number of Openings: 1

Alternative Work Arrangements Available: Flex Time,, Telecommuting,

Relocation Provided: None

Company Trade Name:Merck

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