Central Lab Manager

Responsibilities:

1. Support clinical teams by developing Standard Operating Procedures for the sample collection, processing, shipping, and storage for clinical trials.
2. Prepare and review key study start up documents such as clinical study protocols, clinical kit development, lab manuals and consent forms, and to verify that biological samples are collected as specified in the protocol and related plans.
3. Complete documentation according to cGMP/GLP and all other regulatory agency requirements and archives documents as per applicable policies.
4. Coordinate with clinical operations to ensure that clinical samples are collected, shipped to the appropriate vendors, and coordinates with the vendors to ensure samples are assayed and results are received in a timely manner.
5. Promote and develop process improvements for clinical sample lifecycle management including specimen collection, tracking and downstream storage and/or destruction.
6. Use excellent organizational and multi-tasking skills to perform sample management activities, managing timelines and expectations in a cross-functional manner.
7. Perform other duties as assigned.

Qualifications and experience:

1. BS or higher in scientific discipline required. Minimum 3 years of related experience required; direct clinical operational experience, with exposure spanning initiation through study completion preferred.
2. Proficient knowledge and experience operating within ICH/GXP/GLP/GDP guidelines.
3. Collaboratively work in a cross-functional team and fast paced-environment as well as ability to interact with various levels within the organization and external vendors.
4. Strong organizational and communication skills is essential.
5. Demonstrated ability to work independently and to multitask.
6. Work on site in Boston.