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Senior Specialist, Clinical Data Management Early Development (EDEV) Lead Job Rahway United States,  

Posted on : 15 May 2017

Project Description

Senior Specialist, Clinical Data Management Early Development (EDEV) Lead-CLI005902DescriptionMerck & 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 125-year legacy. 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.Under the direction of the Associate Director/Manager and Associate Director/Project Data Manager (PDM), the Early Development (EDEV) Leads  primary focus is data management-related activities in support of Early Development Phase I studies. The EDEV Lead is responsible for executing end-to-end data management activities pertaining to clinical trials, including but not limited to: data management system design, validation and maintenance, data integrity review and reconciliation, query management, and database lock preparation, in compliance with Merck Standard Operating Procedures (SOPs) and ICH-GCP guidelines.Primary activities include, but are not limited to:- Prepares and delivers the Electronic Data Capture (EDC) system and data review specifications- Prepares and delivers the study specific data management site training materials- Manages and performs data integrity review activities- Serves as the main contact for resolving in-life data issues- Manages and performs the database lock and archiving activities- Is aware of, and adheres to, the project timelines- Identifies project risks and suggests mitigations- May mentor new hires and other EDEV personnel- May act as a Subject Matter Expert (SME) within the EDEV team- Confirms that appropriate documentation is available for assigned studies and adheres to good documentation practices- Is compliant with GDMS SOPs and training requirements- May support or lead any other projects/initiatives or perform any other data management tasks deemed appropriate by managementQualificationsEducation:- B.A. or B.S. degree, preferably in life science, computer science or other health care related discipline.Required:- Minimum 5 years experience in Clinical Data Management, database design/development or related industry experience.Preferred:1. Knowledge of database structures and available tools to manage, extract, and report data is preferred2. Proficient knowledge of the clinical development process, ICH and GCP guidelines3. Excellent written and verbal communication skills with the ability to communicate with both the technical and business areas4. Strong organizational, time management and project management skills5. Ability to present in a group environment6. Ability to establish and maintain good working relationships with the different functional areas and work cross functionally as part of a team7. Ability to work under pressure in a changing environment with flexibility8. Ability to multi-task, work independently, and act with appropriate accountability with minimal guidance by a manager9. Display a sense of urgency and customer-focusYour 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 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.For more information about personal rights under Equal Employment Opportunity, visit:EEOC PosterEEOC GINA Supplement Merck is an equal opportunity employer, Minority/Female/Disability/Veteran  proudly embracing diversity in all of its manifestations. Job: Clinical Data ManagementJob Title:Sr. Spclst, Clinical Data MgmtPrimary Location: NA-US-NJ-RahwayOther Locations: NA-US-PA-West PointEmployee Status: RegularTravel: Yes, 5 % of the TimeNumber of Openings: 1Shift (if applicable): N/ACompany Trade Name:Merck Nearest Major Market: New York City Nearest Secondary Market: Newark Job Segment: Clinic, Database, Medical, Manager, Data Management, Technology, Healthcare, Management, Data


Rahway, NJ, US

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