XE
Xcel EnergyProject Manager II
Project Manager II overseeing large complex projects at Xcel Energy. Leading project management and alignment of financial, compliance, and operational goals.
About the role
- Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements.
- Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
- Lead project team to ensure quality, timelines and budget management.
- Accountable for the financial performance of each project.
- Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
- Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.
- Accountable for all project deliverables for each project assigned.
- Responsible for quality and completeness of TMF for assigned projects.
- Accountable for maintenance of study information on a variety of databases and systems.
- Responsible for study management components of inspection readiness for all aspects of the study conduct.
- Oversight for development and implementation of project plans.
- Plan, coordinate and present at internal and external meetings.
- Prepare project management reports for clients and management.
- Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
- Develops strong relationships with current clients to generate new and/or add-on business for the future.
- May participate in bid defense meetings where presented as potential project manager.
- May be required to line manage other project management team members and clinical monitoring staff.
Requirements
- Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
- Clinical research organization (CRO) and relevant therapeutic experience preferred.
- Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
- Strong organizational skills.
- Strong ability to manage time and work independently.
- Direct therapeutic area expertise.
- Ability to embrace new technologies.
- Excellent communication, presentation, interpersonal skills, both written and spoken.
- Ability to travel as necessary (approximately 25%).
Benefits
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition and total rewards program
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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