Study Manager

Job Overview
Provide project related support and assistance for assigned regionally-based project(s) and project teams. Will ensure all work is conducted in accordance with standard operating procedures (SOPs), policies, good clinical practices (GCP), applicable regulatory requirements, and meets quality/timeline metrics.

Essential Functions
- Establish and maintain all project documentation including all files, records, and reports according to the scope of work and standard operating procedures (SOPS).
- Conduct periodic review/audit of files for accuracy and completeness.
- Coordinate and track all information, communications, documents, materials, and supplies for assigned projects across the region.
- Update and maintain internal systems, databases, tracking tools, timelines, and project plans with project specific information. Act as internal primary contact for project systems and tools.
- Prepare and distribute status, tracking and project finance reports, and assist the project manager(s) with budget allocation and approval of invoices.
- Prepare presentation materials for meetings (internal/external) and project summary data.
- Prepare and present project information at internal and external meetings.
- Coordinate project team and/or customer meetings including logistics and materials required.
- Coordinate with other project support staff within and outside the Clinical Project Management Unit to identify and consolidate support processes.
- Will serve as primary backup contact for internal project team and for external stakeholders/customers as designated by project manager.
- Will undertake project management activities as directed by project manager.
- Train and mentor more junior project support staff, may coordinate their work.

**Qualifications**:

- Bachelor's Degree Bachelor's Degree in life sciences or other related field required Req
- Typically requires 2 - 3 years of prior relevant experience.
- Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.
- 3 years’ relevant experience or equivalent combination of education, training, and experience.
- Good communication and interpersonal skills.
- Good problem solving skills.
- Strong planning and organizational skills.
- Ability to handle conflicting priorities.
- Results and detail-oriented approach to work delivery and output.
- Excellent customer service skills.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.