Senior Clinical Data Manager (remote)

Company: Penfield Search Partners Ltd
Location: Greenville
Posted on: May 12, 2022

Job Description:

Job Description: - Provides oversight for all data management operational activities in support of both clinical and non-clinical research studies from study build through study close. Mentors and trains Clinical Data Management staff.

Primary Responsibilities:
Effectively plan and execute multiple Data Management projects simultaneously. Provide updates directly to senior stakeholders as requested by management.
Serve as a subject matter expert
Participate in Business Development presentations and bid development
Assigns tasks and responsibilities within Data Management to team members that optimizes team capacity, delivery of timely & accurate results and supports the needs of the business.
Provide mentoring and coaching to data management staff in daily operational activities
Communicate with cross functional groups and stakeholders throughout the project lifecycle
Manage sponsor relationships and triage issues as appropriate
Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections
Maintain Quality control of the clinical data, project deliverables and closeouts
Adhere to all aspects company's quality system
Comply with company's data integrity and business ethics requirements
Perform other duties as assigned
Adherence to all essential systems and processes that are required to maintain compliance to business and regulatory requirements

Requirements:
Exceptional working knowledge of clinical trials and the data management role
Excellent organizational and project management skills
Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations
Technical skills with EDC systems, CDMS and other relational databases, and Microsoft Office products
Able to work independently and in teams

Keywords: Penfield Search Partners Ltd, Greenville , Senior Clinical Data Manager (remote), Executive , Greenville, South Carolina