Lead Data Manager - Home based - Oncology Experience

Location
Blue Bell, Pennsylvania (US)
Salary
Competitive salary and benefits
Posted
Apr 11, 2017
Closes
Jun 11, 2017
Hours
Full Time

PRA Health Sciences 

Overview:

The Lead Data Manager (LDM) is responsible for successful delivery of Data Management deliverables meeting internal and external client needs; contributes to Business Development efforts in Data Management. Responsibilities include but are not limited to: Serving as the primary client liaison for Data Management issues; tracking milestones, tasks, and overall budget for assigned projects; ensuring timely completion of all project status reporting; interfacing with internal team members across all departments; developing a plan and overseeing timelines for activities between the last patient’s last visit and database lock; providing study specific training as appropriate; ensuring customer requirements are accurately captured; reviewing Data Management Plans for content and structure; providing case report form design oversight; ensuring quality control steps are properly planned and completed on all studies.

Responsibilities:

• Ensures successful delivery of Data Management deliverables meeting internal and external client needs by:

• Serving as primary client liaison for Data Management issues
• Tracking milestones and tasks for assigned projects
• Tracking overall budget for assigned projects
• Ensuring timely completion of all project status reporting
• Interfacing with internal team members across all departments as needed
• Providing study specific, including protocol training, to extended Data Management team members as appropriate
• Attending client kick off and investigator meetings as required
• Ensure QC steps are implemented so quality deliverables are provided
• Ensuring project deliverables are achieved in terms of timelines and quality
• Identifying and negating study issues early
Contributes to Business Development efforts in Data Management by:
• Participating in bid defense meetings
• Participating in bid and proposal development
• Providing system demonstrations as needed
• Understanding the Data Management technology sales strategy and using the information effectively in Business Development
• meetings


Manages routine tasks for:
• Authoring documents, including (but not limited to): Interim Lock Plan, Database Closure Plan, Database Unlocking Plan
• Reviewing additional Data Management documents to ensure customer requirements are accurately captured
• Actively participating in PRA and Data Management initiatives
• Reviewing study datasets prior to client transfers

Qualifications:

• Undergraduate degree in allied health, bio-medical, related field, or equivalent experience
• Oncology experience required
• Experience working in industry standard Clinical Data Management system(s)
• Experience with all steps within the Data Management lifecycle
• Experience as primary representative of Clinical Data Management project team
• Proven history of successful interaction with internal and external clients and an understanding of related functions
• Proficiency in at least one Clinical Data Management system required
• Experience in most major Data Management study tasks
• Lead Data Manager or related experience required
• Excellent written and oral communication skills.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.