1+ months


Kelly Services
Berkeley Heights, NJ 07922
**BH: 3085443**


Will work 3 days per/week onsite when sites reopen

Our Client is expanding and currently seeks a


**_For a 12-month+ assignment with possible extensions!!_**

Leverage your CLINICAL and PROJECT MANAGEMENT experience to

help take your career with our Client **_to the "Next Level" for 2021 and beyond!!_**

**Location:** Berkeley Heights, New Jersey

**Roles and Responsibilities:**

**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

**Basic Qualifications:**

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)]

**Helpful Skills:**

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

**-There is no per Diem with this position**

**-There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs.**

**-MUST be able to work without sponsorship or VISA transfer for this position.**

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

By partnering with Kelly Technology, youll have direct connections to top companies around the globegiving you the chance to put your tech skills to work on some of todays most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. Were here to help you gain experience, keep learning, and move your career forward.

**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/nontraditional 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.


Posted: 2020-09-23 Expires: 2020-11-23

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Kelly Services
Berkeley Heights, NJ 07922

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