Senior Clinical Project Manager

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 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. • PM will either manage regional trials (moderate complexity) and/or supportive role in managing complex global trials. • Serve as primary point-of-contact and primary escalation point to the client • Coordinate and oversees 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. • 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 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 implements necessary actions in response to those issues • 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 Defence meetings as required • Perform other duties as assigned by management • Remain compliant with organisational training, time-reporting and any other administrative duties as required • Provides on-going feedback for functional team members including annual performance reviews • Ability to travel domestically and internationally including overnight stays

🎯 Requirements

• Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred • Minimum of 3-7 years of clinical research experience or proven competencies for this position and a minimum of 2-4 years of leading a project • Experience managing regional trials (moderate complexity) and/or supportive role in managing complex global trials • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project, eTMF, EDC and CTMS • Good communication and interpersonal skills to effectively interface with others in a team setting • Good organizational skills, attention to detail, and a customer service demeanor.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options