Sr Clinical Project Manager

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 Sr. 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.
C. Essential Job Duties:
? Lead core project team(s) and facilitate team's ability to lead extended/complete 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.
? Provide project focused leadership across departments, offices, external vendors and clients to deliver corporate and department objectives.
? Serve as escalation point for project issues.
? Proactively identify and resolve conflicts as needed.
? Lead implementation of process improvement initiatives on projects as requested.
? Monitor project scope, schedule and costs to ensure all remain on track with the contract. Initiate and implement appropriate actions if needed to get or stay within contract terms
? Proactively lead both quality control and risk management activities to ensure project deliverables are met according to regulatory, client and 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.
? Use lessons learned effectively and contribute to the PMO lessons learned on projects.
? 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.
? 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 SOPs.
? Collaborate with finance to initiate monthly invoicing for both service fees and pass-through costs ensuring budgets for both remain within contract terms.
? Ensure that all staff allocated to assigned project(s) adhere to professional standards and SOPs 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 Project Director.
? Provide performance feedback of team members to respective line managers and engage line management in problem resolution.
? Present at external and/or internal meetings.
? Ensure client satisfaction.
? Define and manage project resource needs as appropriate for the phase of project, ensuring that staff are on-boarded to the project just-in-time and are released from the project when work is completed. Establish and ensure execution of 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 projects.
? Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business.
? In collaboration with relevant departments, contribute to formulation of the delivery strategy assumptions within your area of expertise and as requested. Ensure costing and the payment schedule is in accordance with the delivery strategy prior to contract execution.
? May have line management responsibilities for the recruitment, training, utilization, development and performance review of assigned staff.
? Meet resource management and utilization targets for assigned staff.
? Ensure lessons learned are implemented across projects currently being managed.
? Assist in the development, and implementation of study training plans and execution of training.
? Perform other duties as assigned by management.
I. Experience:
Minimum 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 > six (6) years supervisory experience in a heath care setting and > 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.
? Experience in managing global projects with moderate financial value.
? Demonstrated ability to handle multiple competing priorities.
? Ability to utilize resources effectively on moderate scope projects.
? Financial awareness and ability to actively manage financial tracking systems including moderate projects
? 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.
? Experience mentoring junior level staff.
? 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 packages.
? Ability to assess technology alternatives and implications. In line with relevant functional areas
III. Education/Qualifications/Certifications and Licenses
? 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 (e.g. costing systems, time reporting).
? Detailed knowledge of project management processes.
? Detailed knowledge of time and cost estimate development.
? Detailed 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.
? Experience managing multiple regions, departments and/ or vendors.
? Masters or other advanced degree.
? PMP certification.
Type:Temp/ContractLocation:RemoteExperience:5+ years

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