Job Overview :
Senior Project Manager, Medical Device & Diagnostics
Home-Based Anywherein the United States or Canada
At times working under the direction of a Project Director; the Senior Project Manager oversees and manages domestic, regional and / or international projects.
Responsibilities typically include developing and managing project teams, communications, risk, scope, schedule, cost, quality, and stakeholders, effectively ensuring that variance from plan is proactively and effectively mitigated and client expectations are met.
The Senior Project Manager is expected to have a working knowledge of drug development and clinical trial execution. They also compile and drive documentation for the project, ensuring the accuracy and quality of regulatory data.
The Senior Project Manager may also have line management and / or business development responsibilities.
Serve as key client contact for assigned projects, establishing working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business.
Lead core project team(s) and facilitate team's ability to lead extended project team(s), ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders.
Depending on size and scope of project(s), this job duty may be performed in collaboration with a Project Director.
Serve as escalation point for project issues to internal and external stakeholders, as appropriate.
Proactively identify and resolve conflicts as needed.
Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s).
Monitor project scope, schedule and costs to ensure all remain on track with the contract and with financial performance targets.
Initiate and implement appropriate actions to proactively manage the change control process both internally and externally.
Proactively lead both quality control and risk assurance activities to ensure project deliverables are met according to regulatory, Covance and client requirements.
Create and manage variance to required project plans. Per SOPs, implement and monitor progress against project plans and revise as necessary.
Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs, providing performance feedback to team member’s respective supervisors.
Aid in development and maintenance of key project performance indicators for client specified metrics, ensuring that the KPIs are within scope of the project contract.
Define and manage project resource needs and establish succession plans for key resources.
In collaboration with relevant departments, prepare and deliver presentations for new business as required.
Perform other duties as assigned by management.
Education / Qualifications :
Education Required :
University / college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
Education Preferred :
Masters or other advanced degree.
Minimum Qualifications Required :
4 + years of current experience working as a Project Manager or Senior Project Manager at a CRO managing full-service global trials / studies and the responsibility of the financial management of the studies.
Cardiovascular therapeutic area experience preferred.
Minimum Experience Required :
Minimum of seven (7) years relevant clinical research experience in a pharmaceutical company / CRO, including at least two (2) years of full project management responsibility.
In lieu of the above requirement, candidates with (a) six (6) years supervisory experience in a heath care setting and (b) five (5) years clinical research experience including two (2) years of project management experience (international clinical trial management experience preferred) in the pharmaceutical or CRO industries will be considered.
Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
Working knowledge of project management processes.
Experience managing projects in a virtual environment.
Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
Financial awareness and ability to actively utilize financial tracking systems.
Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
Demonstrated ability to lead by example and to encourage team members to seek solutions independently.
Excellent communication, planning and organizational skills.
Ability to work independently.
Ability to negotiate and liaise with clients in a professional manner.
Ability to present to staff at all levels.
Good computer skills with good working knowledge of a range of computer programs.