Job Overview :
Covance are looking to hire a Project Manager / Senior Project Manager for their Oncology team, we are specifically looking for candidates with CAR T / Cellular experience.
This position can be home or office based in the EU.
Global / Regional ph I-III Clinical Trials
PROJECT MANAGER or Senior PROJECT MANAGER level available depending on experience.
Covance, the drug development business of LabCorp® has supported the pharmaceutical industry develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today.
Our Project Management organization is strong in Europe : 200+ PMs. The Covance s Oncology PM team offers unique opportunities to gain exposure across a broad clinical trial portfolio.
Whether your ambition is to work at the forefront of innovative clinical trial design or play a pivotal role in leading and coordinating global clinical trials in Big Pharma, we have the right job for you.
Lead core project team(s) and facilitate team’s ability to lead extended / complete project team(s). Depending on size and scope of project(s) ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders.
The PM Job duties may be performed in collaboration with a Senior Project Manager and / or Project Director.
Provide project focused leadership across Covance departments, offices, external vendors and clients to deliver corporate and department objectives.
Proactively identify and resolve conflicts as needed.
Monitor project scope, schedule and costs to ensure all remain on track per contract.
Proactively utilize both quality control and risk management activities to ensure project deliverables are met according to regulatory, client and Covance requirements.
Create required project plans. Per SOPs, implement and monitor progress against project plans and revise as necessary.
Proactively manage variance to project plans to bring the study back in line with stated project standards. Monthly metrics reports will be reported accurately and on-time to assist in maintenance of project standards.
Aid in development and maintenance of key project performance indicators for client specified metrics.
Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s).
Meet financial performance targets for assigned project(s). Accountable for budget control across assigned project(s) and accurate month-to-month completion of earned value analysis, as assigned, and evaluation and management of billed time to plan to minimize write-off and capitalize on fixed-price gains.
Proactively identify out of scope activities and execute necessary change orders prior to out-of-scope work being done. Proactively identify project inefficiencies and address issues proactively to stay within budget.
Ensure project procurement needs are managed appropriately and per Covance SOPs.
Collaborate with finance to initiate monthly invoicing as assigned.
Ensure that all staff allocated to assigned project(s) adhere to professional standards and SOP and are working within the assigned allocation.
Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects.
Prepare and actively participate as operational lead in internal Project Review meetings. Depending on size and scope of project, this job duty may be performed in collaboration with a Senior Project Manager and / or Project Director.
Provide performance feedback of team members to respective line managers.
Present at external and / or internal meetings as required.
Ensure client satisfaction.
Define and manage project human resource needs and establish succession plans for key resources.
Responsible for appropriate issue escalation to appropriate stakeholder(s) inclusive of CAIR and CAPA completion as required.
Serve as key client contact for assigned project(s).
Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business.
Prepare and deliver presentations in collaboration with relevant departments for new business as required.
May have line management responsibilities for the training, utilisation, development and performance review of assigned staff.
Perform other duties as assigned by management
Education / Qualifications :
CAR T / Cellular experience
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.
Detailed knowledge of financial control procedures (i.e. earned value analysis).
Working knowledge of project management processes.
Working knowledge of time and cost estimate development.
Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
Broad knowledge of drug development process and client needs.
Masters or other advanced degree.
Working knowledge of Covance and the overall structure of the organization.
Basic knowledge of Covance sales and business development strategies and procedures.
Working knowledge of Covance SOPs.
Experience : Minimum Required :
Minimum Required :
CAR T / Cellular experience
Minimum of five (5) years relevant clinical research experience including demonstrated skills and competency in clinical project management tasks.
In lieu of the above requirements, candidates with >
six (6) years supervisory experience in a heath care setting and five (5) years clinical research experience with at least one (1) year project management experience in the pharmaceutical or CRO industries will be considered.
Experience in 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.
Ability to assess technology alternatives and implications. In line with relevant functional areas