Job Description

Are you actively seeking for a new DATA MANAGER LEAD role in BERKELEY HEIGHTS, NEW JERSEY area? I have a ONE YEAR CONTRACT opportunity with an American biotechnology company that discovers, develops and commercializes medicines for cancer and inflammatory disorders. If you meet the requirements, please send me your updated resume to Kelly.Hua@Yoh.Com.  "YOU MUST BE ELIGIBLE TO WORK IN THE US WITHOUT SPONSORSHIP." 

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.

• 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)]

_Opportunity is Calling, _APPLY NOW! RECRUITER: Kelly Hua

Kelly.Hua@yoh.com

WHAT’S IN IT FOR YOU? 

We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.

• Medical, Dental & Vision Benefits

• 401K Retirement Saving Plan

• Life & Disability Insurance

• Direct Deposit & weekly ePayroll

• Employee Discount Programs

• Referral Bonus Programs

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here! 

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.  Click here to contact us if you are an individual with a disability and require accommodation in the application process.

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