Prozess - und Projektmanager für Mobilitätsservices bei Würzburger Versorgungs - und Verkehrsbetriebe. Eigenverantwortliche Aufnahme und Gestaltung verantwortlicher Prozesse in der Mobilitätsdienstleistung.
SI
Onsite Senior Manager, Global Data Generation
Posted 1 hour ago
About the role
- Senior Manager managing global data generation for clinical oncology studies at Summit Therapeutics. Overseeing operational aspects of studies and collaborating with internal and external stakeholders.
Responsibilities
- Independently manage all operational aspects of studies, including protocol/consent review, document management, fair market value evaluations, contract execution, drug shipments, and maintain ongoing oversight of project to ensure timelines and team goals are met
- Manage the concept proposal intake process, maintain the submission portal and review status, document decisions and communicate with investigators and research coordinators
- Assist with agenda and prepare meeting materials/minutes for Scientific Review Committee meetings
- Responsible for obtaining internal approval of associated study budget, perform Fair Market Value analysis, conducts budget negotiations when needed
- Work closely with Regional Medical Science Directors (RMSDs)/Medical Science Liaisons (MSLs), principal investigators, and other external parties to maintain central progress tracker for all approved proposal to ensure study timelines are met
- Support ongoing analyses, tracking and reporting of study progress versus timelines committed by investigator, data delivery and program impact, and other related metrics
- Track achievement of milestone that trigger payment, and work with Finance to perform budget reconciliation as well as forecast future milestone
- Work with study site/drug supply team to manage and forecast drug supply for the program
- Participate in cross-functional team meetings to provide updates on the program and address any issues or concerns
- Collaborate cross-functionally with internal stakeholders, including medical affairs, clinical development, regulatory, drug supply, etc.
- Adheres to all relevant processes, trainings, and SOPs to ensure consistency, efficiency, and compliance.
- Continued process improvements to ensure consistency, efficiency, and compliance.
Requirements
- Bachelor's or master's degree in the life sciences with extensive relevant experience; an advanced degree (e.g., PharmD, PhD) is preferred
- 5+ years of relevant experience working in clinical trial management in CRO, pharmaceuticals/biotech, or related roles within the pharmaceutical or healthcare industry
- In-depth understanding of the healthcare and pharmaceutical landscape and phases of clinical drug development and processes, including regulatory requirements
- Familiarity with software platforms for managing ISTs (e.g. iEnvision ISR platform) and tools and fair market value analysis (e.g. IQVIA GrantPlan for Investigators)
- Scientific and medical terminology acumen, experience in Oncology strongly preferred
- Strong organizational skills, attention to detail, critical thinking and high problem-solving abilities
- Excellent communication and interpersonal abilities
- Ability to work collaboratively across diverse teams and manage multiple stakeholders
- Proficient user of the standard MS Office suite (e.g., Word, Excel, PowerPoint); experience with electronic document management systems and document review tools is desirable
- Self-motivated, ability to multi-task and work independently and achieve success with little oversight or guidance
- Able to travel as necessary up to 10-20% of the time.
Benefits
- Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location.
- The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
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