Precision Medicine Group ยท 1 day ago
Senior Project Manager
United States
Full-time
Remote
Senior Level
$147K/yr - $221K/yr
7+ years expPrecision Medicine Group is seeking a Senior Project Manager to lead clinical study projects. The role involves planning, directing, and coordinating project activities to ensure objectives are met while maintaining quality, scope, and budget.
BiotechnologyHealth Care
Responsibilities
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. Independently drive the CO to completion and execution with support as needed
Maintain integrated collaboration with clinical operations in the delivery and participates 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
Leads 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
Ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defenses 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 organizational training, time-reporting and any other administrative duties as required
Provides on-going feedback, for functional team members including annual performance reviews
Qualification
Required
North America: Bachelor's degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
EU: Degree or equivalent combination of education/experience in science or health-related field. 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
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
Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items
Proven knowledge of project management 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 communications skills
Good understanding of project management software
In depth proven experience in pharmaceutical and/or device research required
Preferred
experience with autoimmune disorder and rare disease
Benefits
Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave and vacation
Company
Precision Medicine Group
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Mark Clein
Co-Founder & Chief Executive Officer
Matt DeZee
Chief Financial Officer
Company data provided by crunchbase