The Asst. Study Start Up Manager is responsible for assisting with all aspects of the Study Start life cycle within the Program Management Organization (PMO). This role coordinates all Study Start Up staff. This role will also provide a link to the Manager, SSU through which all escalations and resolutions flow.
DUTIES & RESPONSIBILITIES
- Proactively manages of all Study Start Up activities after site selection is received
- Provide assistance to Manager, SSU on core operational elements involved in the execution and delivery of clinical trials within the Study Start Up life cycle
- Ensures all Study Start Up and contracting deliverables meet the internal and external customers expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk identification, mitigation and management.
- Develops and maintains relationships with customers in alignment with Study Start Up
- Develops and manages integrated site start-up timelines and reports weekly progress including plans to address potential timing risks/gaps.
- Collaborates and ensures strong communication with the project management team, including any realignment required due to amendment needs.
- Any other matters as assigned by management
KNOWLEDGE & EXPERIENCE
Education:
- Bachelor’s Degree in Business or Management preferred
- 3+ years of related clinical trial Study Start Up management experience
- High level of experience managing multidisciplinary teams
- Strong knowledge and handling of clinical trial Study Start Up and contracting methodology and techniques
- High level of understanding of the wider objectives of the program
- Ability to work positively with the wide range of individuals involved in program and project management
- Strong leadership and management skills
- The ability to find innovative ways to resolve problems
- Excellent verbal and written communication skills
- Excellent interpersonal and customer service skills
- Excellent organizational skills and attention to detail
- Excellent time management skills with a proven ability to meet deadlines
- Strong analytical and problem-solving skills
- Ability to function well in a high-paced and at times stressful environment.
- Proficient with Microsoft Office Suite, Google Suite, or related software.
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