Job Description :
Company Overview:

Creating value by bringing together the right people to achieve results is our motto. Our clients and employees say they choose to work with us because of how we work with them - with service that exceeds their expectations and a personal commitment to their success.

Our client, is the world''s largest independent multinational biopharmaceutical company, seeks an accomplished Senior Project Manager.

Must have: Lack of pharma or biotech experience, EDC programming experience as primary skillset, Data Management as primary skillset, Lack of project management experience.
Interview Type: In person interviews with a few team members.

This role also has a high rate of FTE conversion, when FTE opportunities become available.
The position will work with cross-functional teams responsible for executing clinical trials, as well as IVRS supplier (vendor) Project Managers to support the design, implementation and maintenance of outsourced Interactive Voice/Web Response Systems (IVRS
The role provides technical and project management oversight to ensure that the system designed for the study adheres to the study’s protocol, industry regulations / best practices, and client policies, procedures and guidelines.
This role is an active participant of the ETO team, attending team meetings and contributing to team forums and process improvements.
Lead and facilitate system requirements gathering meetings with clinical study teams and IVRS design PM.
Design and oversee the development of study-specific IVRS technical documents. Document issues and risks, and implement mitigation plans in partnership with study team and vendor PM.
Identify and track study-related technical issues to resolution. Closely manage project-related timelines and associated activities.
Complete SOP training per client requirements. Review and understanding of process manuals. CW will be assigned a “buddy” who will be available throughout the duration of the contract to provide consult, supplemental on-the-job training, and study-specific advice when needed.
Intensive training on ETO processes: IXRS system involves patients and so appropriate training is extremely important. We have a robust onboarding process to ensure our CW can appropriately do the work with confidence. Training includes:
o facilitating system requirements gathering for IVRS systems
o understanding system design as it relates to clinical protocol
o Understanding ETO UAT processes
o TMF filing requirements
o Issue management
o Vendor management structure

Master''s Degree and at least 3 years of Clinical experience OR Bachelor''s Degree and at least 5 years of Clinical experience.
Drug development experience, preferably in clinical study management or clinical system management (IVRS preferred
Project management experience, including strong meeting management skills is strongly preferred.
Knowledge of clinical drug supply process preferred.

Preferred Requirements:
Bachelor’s Degree in life science, computer science, engineering, business or related discipline.
PMP certification.
4 or more years of experience in clinical operations, clinical supply chain or clinical systems management.
Experience implementing clinical systems, such as IVRS and eCOA. Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution.
Must be detail-oriented and able to manage many projects simultaneously. Excellent documentation and communication skills are critical. Meeting management and facilitation skills are a must.
Vendor management experience is preferred. Excellent time management and organization skills are essential in a timeline-driven environment.
Must have sound problem resolution, judgment, and decision-making abilities. Must be able to work well in a team-based environment with minimal supervision.

I''d love to talk to you if you think this position is right up your alley.

If you''re looking for rewarding employment and a company that puts its employees first, we''d like to work with you. We''re driven, people driven. We also offer group health Insurance (employee paid on a pre-tax basis

NOTE: “Candidates that are offered a position are required to pass pre-employment drug and background screening”