POSITION SUMMARY:

The Biospecimen Registration and Reconciliation Manager is responsible for overseeing and reviewing the registration of biospecimens for the CorEvitas Precision Medicine Biorepositories within the Laboratory Information Management Systems (LIMS) and identifying biospecimen quality and biospecimen related data discrepancies. The role will have primary responsibility for reconciling discrepancies via interaction with clinical sites, central laboratories, and internal stakeholders, ensuring compliance and traceability of biospecimens and related data, and support and interface with departmental, interdepartmental team members, and central laboratories to support all activities and reporting through the biospecimen life cycle.

PRINCIPLE DUTIES AND RESPONSIBILITIES:

1. Review biospecimens registered in the LIMS and across databases based upon biospecimen best practices, standard operating procedures, work instructions, and study-specific and matrix-specific requirements, approve biospecimens meeting standards, and identify biospecimen and biospecimen related data discrepancies. (20%)
2. Fully reconcile biospecimen and biospecimen related data discrepancies via interaction with clinical sites, clinical registry managers, and central laboratories. Make appropriate updates to data in the LIMS and other databases while ensuring compliance and traceability of the reconciliation process are captured. Provide recommendations and follow-up on problems to Biorepository Director including requests for biospecimen and biospecimen related data destruction. (20%)
3. Monitor and identify clinical biospecimen acquisition and central laboratory handling and data entry issues and make recommendations for process and system improvement including contributing to collection and shipping kit design, standard operating instructions, work instructions, guidance documents, clinical site laboratory collection manuals, and training documents. Coordinate agreed upon changes with internal and external stakeholders. (15%)
4. Coordinate with central laboratory and biorepository team for supplies and logistics of collection and shipping kit delivery to clinical sites and provide projections and oversight related to quarterly and annual team objectives. (5%)
5. Create, distribute, and present biospecimen acquisition metrics and reports to relevant study teams and participate in data development of reports. (10%)
6. Coordinate biospecimen registration approval with Biorepository and study team members to meet needs for downstream testing, storage, and shipments and with clinical registry management needs. (10%)
7. Maintain technical knowledge and ensure compliance with clinical and laboratory best practices for biospecimen and biospecimen related data acquisition at clinical sites and biospecimen transport and processing at central laboratories (5%)
8. As a part of the Precision Medicine team, contribute to team goals and the development of new biorepository collections and studies including LIMS and database development (15%)

MINIMUM QUALIFICATIONS :

Skills/Knowledge:

Proficiency with Microsoft Word, Excel, and PowerPoint

Knowledge and familiarity with standard biospecimen processes and biospecimen related data acquisition, sample analysis, sample storage and laboratory data management systems such as a LIMS or other databases.

Attention to detail and ability to manage differing studies within standards.

Demonstrated application of critical judgement, and problem solving, preferably in biomedical research.

Ability to work independently with time and project management skills

Enjoy working within a virtual team environment at various levels and from various fields to achieve objectives.

Experience:

At least two years of experience in managing biospecimens and associated data, preferably with clinical biospecimen experience including troubleshooting of biospecimen processing.

Experience in interfacing with central and/or testing laboratories and/or or biorepositories

Experience with LIMS or other laboratory databases preferred

Education/training:

Bachelor’s Degree, preferably in a scientific discipline or health-related field

About CorEvitas

CorEvitas, now part of Thermo Fisher Scientific is a science-led, real-world data intelligence company. Using syndicated registry data and analytic services to understand the post-approval comparative effectiveness and safety of approved therapies, CorEvitas provides biopharmaceutical companies with objective data and clinical insights to demonstrate the value of their products to clinicians, patients, payers, and regulators. The company operates nine major autoimmune and inflammatory registries across the U.S., Canada, and Japan, collecting data from over 400 participating investigator sites, including collection of biosamples linked to the deep clinical data. CorEvitas recently expanded its services to include Pregnancy Registries, through the acquisition of Pregistry. CorEvitas also conducts client-sponsored registries through its Patient Powered Registries business, employing a transformative patient-focused registry model to support research needs for patient-centered outcomes across all therapeutic areas. The company’s regulatory-grade registry data is complemented by its Patient Experience business, supporting evidence-based patient engagement initiatives across the product lifecycle, as well as its Specialty EMR Data business and retinal data set. CorEvitas is headquartered in Waltham, MA. www.corevitas.com

CorEvitas is proud to provide equal employment opportunities to all qualified individuals without regard to race, color, religion, sex, gender identity, sexual orientation, pregnancy, age, national origin, physical or mental disability, military or veteran status, genetic information, or any other protected classification. Minorities, women, LGBTQ candidates, Veterans, and individuals with disabilities are encouraged to apply.

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