Position Summary
The 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 support a global trial as a lead PM. In a supportive role the essential functions will be delegated by the Global Lead.
Essential Functions
* Serve as primary point-of-contact and primary escalation point to the client.
* Coordinate and oversee all functional services including external vendors to meet the established timeline and budget.
* Manage the study budget, ensuring the project remains within scope and that out-of-scope activities are identified early and handled appropriately.
* Ensure functional areas are fully aware of the study scope and manage their scope accordingly.
* Manage the financial health of assigned studies, including oversight of project profitability, billable hours, and compliance with on-time, accurate billing and forecasting to support business objectives.
* Develop robust and comprehensive project plans, including timelines, 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 preventive action plans to address any quality findings.
* Maintain integrated collaboration with all functional operations in the delivery of the program and review study documentation as necessary.
* Establish tracking metrics to monitor trial and team progress toward 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 the client and Precision management to relay protocol/study issues, including any deviations, and implement necessary actions in response.
* Ensure study‑specific training is implemented in collaboration with functional areas and ensure 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.
* Provide ongoing feedback for functional team members, including annual performance reviews.
* Travel domestically and internationally, including overnight stays.
Qualifications
* Degree or equivalent combination of education/experience in a science or health‑related field. Advanced degree preferred.
* Minimum of 3‑5 years of clinical research experience or proven competencies for this position, and a minimum of 2 years of leading a project.
* Experience managing regional trials (moderate complexity) and/or supporting global trials.
Other Required Skills
* Experience with Microsoft Office products (Outlook, Word, Excel, PowerPoint), Microsoft Project, eTMF, EDC and CTMS.
* Good communication and interpersonal skills to interface with others in a team setting.
* Good organizational skills, attention to detail, and a customer‑service demeanor.
Competencies
* Demonstrates knowledge of ICH‑GCP, relevant Precision SOPs, and the ability to implement such items.
* Working knowledge of project management techniques and tools.
* Experience working in a cross‑functional project management environment.
* Fundamental understanding of cross‑functional management and project planning, risk management, and change management.
* High level of integrity, demanding the highest standards from a professional and ethical perspective.
* Ability to lead and inspire excellence within a study team and create an environment where team members have ownership to increase productivity and efficiency.
* Results‑oriented, accountable, motivated, and flexible.
* Strong time management, negotiation, critical thinking, decision making, analytical and interpersonal skills.
* Good presentation, verbal and written communication skills.
* Fundamental understanding of project management software.
* Experience in pharmaceutical and/or device research required.
We invite you to learn more about our growing organization serving clients researching groundbreaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will have the opportunity to provide input and have your ideas valued and nurtured, impacting positive change for the company.
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
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