Clinical Project Director

Precision for Medicine is not your typical CRO.
At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.
What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.
We have a strong focus on Oncology and Rare Disease.Due to our growth we are seeking a Project Director.The Project Director represents continued advancement upon the project management career track.
Responsibilities are defined below and are dependent upon the type and timing of the program to which the Project Director is assigned but are generally associated with global or large studies or a program of studies.
Commonly, the Project Director may be called upon to serve as Portfolio Manager of a suite of studies for a significant client.
The Project Director is a critical position that may be called upon to support the Senior Leadership in ensuring continuous process improvement to support strategic company objectives in project execution.Essential functions of the job include but are not limited to:Serve as primary point-of-contact liaison with client to provide outstanding customer service, including participation in proposal activities and client presentationsOversee and manages all aspects of a clinical research trial or trials, ensuring consistency across assigned portfolios.Provide direction to project managers assigned to their trials including project establishment, planning, initiation, procurement, execution and closingManage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate.
Drive any needed change orders to completion and execution with minimal support.
Ensure functional areas are fully aware of the study scope and are managing the scope for their functional areas accordingly.Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives.Develop or oversee the development of, robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality.
Able to implement strategic planning, risk management and change management with the ability to implement these independentlyEnsure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings.Establish tracking metrics to monitor trial and team progress towards project goalsPrepare project status updates for clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise.
May be required to attend additional Senior management meetings, to offer further insight and presentations on assigned studies.Lead both internal and client meetings and set expectations for the project team, driving the program or study level strategies forwards with the project teamOversee the cross-functional project team, ensuring efficient management and execution of trialsCommunicate effectively with both sponsor and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issuesAbility to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defences with a high level of proficiencyEnsure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the projectSupport business development and marketing activities as appropriate, including travel to Bid Defense meetings as required.
As Project Director, proactively drive the Bid defense preparation activities.Perform other duties as assigned by managementRemain compliant with organisational training, time-reporting and any other administrative duties as requiredMentor associate project managers, project managers or Senior project managers as requiredParticipate in the departmental updates, such as the development and updates of company SOPs as neededProvides on-going feedback for functional team members including annual performance reviewsIdentify any performance problem at a project level and ensure an operational corrective action is undertaken (training etc.)Ability to travel domestically and internationally including overnight staysQualifications:EU: Degree or equivalent combination of education/experience in science or health-related field.
Advanced degree preferredOther Required:Minimum of 8 years of clinical research or proven competencies for this position.
A minimum of 5 years direct project management experienceHighly proficient with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project, eTMF, EDC and CTMSExcellent communication and interpersonal skills to effectively interface with others in a team settingExcellent organizational skills, attention to detail, and a customer service demeanorExperience managing highly complex and global studies or a portfolio of studiesMust have fluency in English and MandarinPreferred:Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such itemsExcellent knowledge of project management techniques and toolsHighly experienced at working in a cross-functional project management environmentStrong understanding of cross-functional managementStrong understanding of project planning, risk management and change management with an awareness of appropriate escalationHigh level of integrity and must inspire and demand the highest standards from a professional and ethical perspectiveAbility to lead and inspire excellence within a study team.
Motivates other members of the project team to meet timelines and project goalsAbility to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiencyResults oriented, accountable, motivated and flexibleDemonstrated excellence in time management, negotiation, critical thinking, decision making, analytical and interpersonal skillsDemonstrated excellence in presentation, verbal and written communications skillsExpert understanding of project management softwareHighly experienced in pharmaceutical and/or device research requiredDemonstrated expertise in strategic planning, risk management and change management with the ability to implement independentlyHighly developed customer orientationHighly developed influence, negotiation and conflict management skillsExhibits high self-motivation and is able to work and plan independently as well as in a team environment.Focuses on continuous improvement, including the ability to make proactive assessments on how to make study processes more efficient and study teams more effectiveWe invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies.
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Precision Medicine Group is an Equal Opportunity Employer.
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