Project Manager - Clinical Trials
Project Manager - Clinical Trials
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$ 98700 - 183300
1 Vacancy
Job Description
Job Description Summary
The Project Manager will manage assay development and/or clinical trial project lifecycles. This includes the daytoday management of assigned assay development projects and clinical trials performed at Navigate BioPharma Services in support of drug device and combination clinical trials. Managing assay development or clinical trial projects require ensuring ontime delivery of services and milestones resolving issues assuring the project remains within budget and adhering to Navigates quality standards. This role is an essential bridge between the sponsor external stakeholders and the Navigate business serving as the primary point of contact for each project.Job Description
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Establish and maintain effective communication channels with relevant internal and external project stakeholders throughout entire project lifecycle. Disseminate project updates issues and modifications to teams in a proactive and timely manner.
- Monitor project timelines to ensure ontime execution and completion of project deliverables and milestones. Collaborate with sponsor and internal team to accurately forecast project billables and complete billing.
- Control project scope to ensure project is staying within budget and identify scope changes to ensure modifications are captured appropriately in change orders.
- Proactively identify risk develop mitigation plans and resolve issues. Escalate critical problems to management and project stakeholders.
- Author studyspecific documentation including presentations; lead internal and external meetings and develop agendas and minutes.
- Manage assay development projects that may have IDE or IVD requirements including those with product development under design control. Lead timeline management for assay development projects coordinating and aligning stakeholders for joint success. Be able to manage a larger number of clinical trial projects and/or multiple project portfolios clinical trials with higher complexity including those that require partner lab setup and testing turnaround time expectations and real time sample incident resolution.
- Demonstrate critical thinking skills and strategic planning in project execution and risk management.
OTHER RESPONSIBILITIES
- Work in a GMP/GCP/GLP/CLIA regulated environment and be responsible for following all applicable regulations.
- Ensuring that Quality Events such as incidents and deviations are properly documented and supporting/owning the immediate remediation and preventative actions
- Ensuring change requests are properly initiated completed and approved prior to the use of the assay system instrument software etc. being changed
- Maintaining uptodate training records and ensuring training is complete prior to performing specific job functions
- Following approved and effective procedures to perform specific job functions and ensuring procedures accurately reflect activities being performed
Essential Requirements
- Bachelors degree in a sciencerelated field (Related Project Management coursework and/or experience strongly desire).
- Minimum of three (3) years related project management experience in a relevant industry is preferred.
- A strong customer and service focus is essential.
- Strong communication skills are also required to ensure that project schedules and client expectations are met or exceeded.
- Demonstrated ability and success in fostering internal and external collaborations.
- Demonstrated success working in a team. Must be able to influence without authority.
- Must be able to work in a team setting trouble shoot be adaptable and foster collaborations.
- Strong scientific background is essential.
- Strong organizational and program management skills.
- Knowledge of logistics and clinical trial operations.
- Knowledge of FDA regulation of clinical trials; GCP and 21 CFR is strongly recommended. Product development under design control desired.
- Project management certification is a plus.
- Demonstrated understanding of or experience with financial modeling strongly desired.
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion sex national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position please send an email to or call 1(877)and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$98700.00 $183300.00Skills Desired
Building Construction Business Development Business Partners Business Planning Business Transformation Compensations Management (Employees) Finance GoToMarket Strategy Influencing Skills Labor Law Leadership Lean Six Sigma Management Consulting Outsourcing Pmi (PostMerger Integration) Project Delivery Project Execution Projects Coordination Strategic Planning Value PropositionsRequired Experience:
IC
Employment Type
Full-Time
