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Clinical Data Manager

BCforward Berkeley Heights ,NJ
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Duration: 12 Months

 

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

 

Required

• Bachelor’s 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)].

 

Thanks

Vasantha

Company Description
About BCforward
BCforward began as an IT business solutions and staffing firm. Founded in 1998, BCforward has grown with our customers’ needs into a full-service personnel solutions organization. BCforward’s headquarters are in Indianapolis, Indiana and also operates delivery centers in 17 locations in North America as well as Hyderabad, India and Puerto Rico. We are currently the largest consulting firm and largest MBE certified firm headquartered in Indiana. With 14+ years of uninterrupted growth, the addition of two brands (Stafforward and PMforward) and a team of more than 1400 resources our teams deliver services for multiple industries from both public and private sectors. BCforward’s team of dedicated staffing professionals has placed thousands of talented people over the past decade, with retention rates that are consistently higher than the industry average.

www.bcforward.com

BCforward

Why Work Here?

What makes BCforward different is our people and how we do business. We pride ourselves on locating and hiring the best resources in NY.

About BCforward BCforward began as an IT business solutions and staffing firm. Founded in 1998, BCforward has grown with our customers’ needs into a full-service personnel solutions organization. BCforward’s headquarters are in Indianapolis, Indiana and also operates delivery centers in 17 locations in North America as well as Hyderabad, India and Puerto Rico. We are currently the largest consulting firm and largest MBE certified firm headquartered in Indiana. With 14+ years of uninterrupted growth, the addition of two brands (Stafforward and PMforward) and a team of more than 1400 resources our teams deliver services for multiple industries from both public and private sectors. BCforward’s team of dedicated staffing professionals has placed thousands of talented people over the past decade, with retention rates that are consistently higher than the industry average. www.bcforward.com

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Berkeley Heights, NJ
07922 USA

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