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22 days old

Data Management Lead / Berkeley Heights, NJ

Kelly Services
Berkeley Heights, NJ 07922
**Data Management Lead / Berkeley Heights, NJ**



Kelly Services is currently seeking a Data Management Lead for one of our top clients in Berkeley Heights, NJ.




+ Duration = 12+ Months from start date

+ Typical Daily Work Hours = 40 hr/week, 8am-4pm (with some flexibility in start/end times as long core hours are covered)

+ No Overtime.

+ 100% Onsite Work (Worker will start out working remotely, but when COVID site restrictions are lifted, work will resume 100% onsite)



**Responsibilities will include, but are not limited to:**




+ Project Management and Leadership

+ Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects

+ Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects

+ Responsible for end to end clinical data management activities and serves as a primary point of contact for internal and external study team members

+ Provides strong quality and project oversight over third party vendor responsible for data management deliverables

+ Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes

+ Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization

+ Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency , quality and completeness

+ Represents DM on cross-functional project teams & submission Teams

+ Lead or support the Health Authority inspections and audits

+ Provides coaching and quality oversight of junior Data Management Leads FSP/CRO/Vendor Oversight

+ May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA) Continuous improvement initiatives

+ Provides the relevant support and input to continuous improvement activities within clinical data management

+ Provides support for CAPA implementation as required



**KNOWLEDGE/SKILLS/ABILITIES (KSA's):**




+ Bachelors Degree required with an advanced degree preferred

+ At least 5 years of relevant industry experience.

+ Project management certification (e.g. PMP) is desirable.

+ **Manager ONLY wants candidates that have actual LEAD data manager experience.**

+ Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors

+ Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management

+ Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection

+ Strong project management; Exhibits expertise in metrics analysis and reporting methodologies

+ Excellent oral and written communication skills

+ Communicate effectively with senior management and cross-functional teams
Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License

+ Application (BLA)/Market Authorization Application (MAA)]





Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Email stalvnl@kellyservices.com for questions about the position but please apply online to be considered for the position.





Why Kelly?




+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire*





Apply Today!





*Available for purchase and administered by a designated third-party vendor




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-10-07 Expires: 2020-11-07

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Data Management Lead / Berkeley Heights, NJ

Kelly Services
Berkeley Heights, NJ 07922

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