Senior Clinical Project Manager / Clinical Project Manager
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.
Position Summary
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 provide a supportive role in managing complex global trials. The essential functions below describe the PM acting in a primary / lead PM role on a study. When in a supportive role on a global study, the essential functions are 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 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 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 quality findings.
* Maintain integrated collaboration with all functional operations in the delivery of the program and review other study documentation as necessary.
* Establish tracking metrics to monitor trial and team progress toward project goals.
* Prepare project status updates and report progress to clients and senior management, including key performance indicators and offering solutions and opportunities as they arise.
* Lead internal and client meetings and set expectations for the project team.
* Communicate effectively with client and Precision management to relay protocol/study issues, including deviations and implement necessary actions.
* Ensure study‐specific training is implemented in collaboration with functional areas and enforce 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 other administrative duties as required.
* Provide ongoing feedback for functional team members, including performance reviews.
* Travel domestically and internationally, including overnight stays.
Qualifications
Minimum Required
* Degree or equivalent combination of education/experience in a science or health‐related field. Advanced degree preferred.
* Minimum of 4–7 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 supporting role in managing complex global trials.
Other Required
* Experience with Microsoft Office Products, Microsoft Project, eTMF, EDC and CTMS.
* Good communication and interpersonal skills.
* Strong organizational skills, attention to detail, and a customer‐service demeanor.
* Mandarin speaking required to cover East Asia market.
Competencies
* Knowledge of ICH‐GCP, Precision SOPs, and 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, project planning, risk management, and change management.
* Integrity and high standards of professionalism.
* Leadership and ability to inspire excellence within a study team.
* Ability to create an environment fostering ownership and productivity.
* Results‐oriented, accountable, motivated, and flexible.
* Strong time management, negotiation, critical thinking, decision‐making, analytical and interpersonal skills.
* Strong presentation, verbal and written communication skills.
* Experience in pharmaceutical and/or device research required.
Additional Information
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 provide input and have your ideas valued and nurtured, impacting positive change for the company.
Equal Opportunity Employment
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.
#J-18808-Ljbffr