Study Start Up Manager
2 weeks ago
The Study Start Up Manager is responsible for overseeing all aspects of the study start life cycle within the Program Management Organization(PMO). This role provides direct leadership to all study start up staff and contracting staff. This role will also provide a link to senior leadership through which all escalations and resolutions flow.
DUTIES & RESPONSIBILITIES:
- Provides oversight and management of all study start up and contracting activities and study start up as well as contracting staff within the PMO
- Identifies and evaluates fundamental issues pertaining to study start up, project regulatory pathway and contracting and interprets data on complex issues, making good business decisions, and ensure solutions are implemented as directed by senior leadership team
- Orchestrate, in conjunction with senior leadership, the core operational elements involved in the execution and delivery of clinical trials within the study start up life cycle and contacting verticals
- 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 and contracting services,
- Assumes accountability on start-up deliverables including, but not limited to:
- Oversight of delivery of executed clinical trial agreements and investigator budgets with investigator sites, including any require amendments
- Overseeing Essential Document collection and delivery leading to site activation
- Development and oversight of overall SSU and contracting timelines, prior to site activation (SSU) and following site activation (Contracting). Including any realignment required due to amendment needs.
- Develops and manages integrated site start-up timelines and reports weekly progress including plans to address potential timing risks/gaps.
- Prepares and presents overall SSU strategy and status at client meetings.
- 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
- 5+ years of related clinical trial study start up management experience
- 2+ years of related clinical trial contracting 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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