[Hiring] Senior Clinical Project Manager @Precision Medicine Group

Role Description

The Senior/Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.

• Serve as primary point-of-contact and primary escalation point to the client.
• Coordinate and oversee all functional services including external vendors to the established timeline and budget.
• Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate.
• Independently drive the CO to completion and execution with support as needed.
• Maintain integrated collaboration with clinical operations in the delivery and participate in clinical activities as appropriate.
• For projects of very limited scope (i.e. number of sites), Sr. PM may assume all clinical activities.
• 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 robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality.
• Ensure 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.
• Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation.
• Establish tracking metrics to monitor trial and team progress towards project goals.
• Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise.
• Lead both internal and client meetings and set expectations for the project team.
• Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implement necessary actions in response to those issues.
• Ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defences with proficiency.
• Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project.
• Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required.
• Perform other duties as assigned by management.
• Remain compliant with organisational training, time-reporting and any other administrative duties as required.
• Provide ongoing feedback for functional team members including annual performance reviews.

Qualifications

• Bachelor’s degree or equivalent combination of education/experience in science or health-related.
• Advanced degree preferred.
• Minimum of 7 years of clinical research experience or proven competencies for this position and a minimum of 4 years of direct project management experience.
• Experience in managing complex and global trials.
• Ability to travel domestically and internationally including overnight stays.

Requirements

• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project, eTMF, EDC, and CTMS.
• Proven communication and interpersonal skills to effectively interface with others in a team setting.
• Proven organizational skills, attention to detail, and a customer service demeanor.

Competencies

• Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items.
• Proven knowledge of project management techniques and tools.
• Direct work experience in a global, cross-functional project management environment.
• Good understanding of cross-functional management.
• Good understanding of project planning, risk management, and change management with an awareness of appropriate escalation.
• Proven experience in strategic planning, risk management, and change management.
• High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective.
• Ability to lead and inspire excellence within a study team.
• Ability to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiency.
• Results oriented, accountable, motivated, and flexible.
• Proven time management, negotiation, critical thinking, decision making, analytical, and interpersonal skills.
• Proven presentation, verbal, and written communication skills.
• Good understanding of project management software.
• In-depth proven experience in pharmaceutical and/or device research required.