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Position Overview

The Study Management Specialist is responsible for ensuring that incoming clinical trial and research projects are appropriately entered into laboratory information systems (LIMS) to ensure data integrity and conformance to project requirements prior to release of samples to the production laboratory operation.

Key Responsibilities and Essential Functions

Prepare and verify that project manifests accurately represent customer sample data, processing instructions, and data delivery specifications. Escalate non-standard issues to team or management.
Regularly meets activation turn-around-time (TAT).
Collaborate with customer-facing teams to resolve sample data discrepancies and obtain missing information.
Attend regular meetings with internal stakeholders.
Monitor progression of projects through BSM to resolve blockers and ensure turn-around-times are met.
Follow sample programming instructions in project maps for incoming samples, as defined in customer agreements.
Liaison with business groups to obtain forecasting and deadline information. Report collected information to larger BSM team.
Identify process interruptions, stalls and special handling needs. Propose solutions and assist in resolutions of such events.
Complete functions conforming to applicable regulations (CLIA, GCLP) as dictated by analytical plans, work orders or other project requirements.
Collaborate with team to compile status summaries and data reports.
Edit SOPs and other documents specific to Study Management functions.
Participate in the development of new workflows as business needs arise.
Assist in training fellow Study Management Specialists in job functions.
Perform other duties as assigned by the Study Management Manager or Supervisor
Regulatory responsibilities per Good Clinical Practices (GCP), CAP, and CLIA

Position Requirements (Education, Experience, Other)

Required

BS/BA degree in biology or related science
Some previous related experience required (clinical lab preferred)
Ability to identify and communicate issues while proposing possible solutions.
Self-motivated and able to work with minimal supervision while also working as part of a team
Strong interpersonal and communication skills, both written and spoken
Ability to read, write, speak and understand English.
Strong analytical and planning skills
Excellent problem-solving skills
Meticulous attention to details and deadlines
Proficiency with Microsoft Word and familiarity with use of web-based applications

Preferred

Previous work in a regulated clinical environment and/or familiarity with GCLP practices
Previous experience working with laboratory information management systems and Salesforce.
Advanced Excel skills (including but not limited to VLOOKUP, IF/THEN statements and pattern matching within excel files)

Working Conditions

Job involves working in a fast-paced operations environment with fluctuating priorities and deadlines. Requires flexibility and willingness to work more than standard hours when necessary, including holidays.

Physical Requirements

Individuals are required to sit or stand for much of the workday and perform data entry into computer systems.

Compensation

Hourly Rate: $30.24 - $45.33

Other compensation elements include:

equity grant

ALERT: Malicious groups posing as Adaptive employees have recently used fraudulent email aliases to extend employment offers, provide fake documents, and request sensitive personal and financial information. Legitimate Adaptive employment opportunities are initiated through our careers page and extended after multiple interviews with verified employees. Adaptive does not ask new hires to purchase anything out-of-pocket, including home office supplies and equipment.

Interested in this position, but don’t meet all the requirements? Adaptive is committed to building diverse, equitable, and inclusive teams across our organization. Please consider applying even if your experience doesn’t match all the qualifications; you may be the exact candidate we’re searching for!

Adaptive is not currently sponsoring candidates requiring work authorization support for this position.

Adaptive’s posted compensation information includes a base salary (or hourly rate) range and summary of other available total compensation. The base salary range represents a minimum-to-maximum salary (or hourly rate) available to candidates upon extension of offer. Base salary is thoughtfully considered upon offer and is determined through multiple evaluation checks throughout the interview process, including: a candidate’s ability to meet minimum qualifications (skills/experience/education), a candidate’s ability to thoughtfully address preferred qualifications, current market conditions, and internal pay equity. Listed base salary is exclusive of bonus, commission, equity, differential pay, benefits, and other incentives.

Adaptive's benefits at-a-glance.

Adaptive Biotechnologies is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. Please refer the Equal Employment Opportunity Posters for more information. If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email hr@adaptivebiotech.com.

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NOTE TO EMPLOYMENT AGENCIES: Adaptive Biotechnologies values our relationships with our Recruitment Partners and will only accept resumes from those partners who have active agreements with Adaptive. Adaptive Biotechnologies is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Adaptive Biotechnologies who is not a member of the Human Resources team.

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Study Management Specialist (IM Business)

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