Essential Responsibilities
- Partner with internal and external stakeholders to define and monitor project timelines
- Ensure that projects remain on schedule and appropriately resourced
- Track project samples received, tested, and reported.
- Maintain accurate study records including documentation received and discrepancy / reconciliation activities
- Coordinate with Central Lab and/or Data Analytic group for Data Transfer Agreement setup and file transfer.
- Track Long Term Stability Timepoints
- Ensure great customer experience
- Maintain a strong working relationship and open communications with all departments, including Quality Control, Quality Assurance and Sample Management
- Prepare Sample Analysis worklists
- Support Sample Analysis Plan generation
- Support Quality review data submission
- Manage resource planning and project database systems
- Support Business Unit lead time management
- Manage revenue recognition activities for sponsor projects supported
- Proactively identify contract amendments required
- Support team scheduling
- Manage Client Specific Metrics and Tracking
- Support Operational Excellence Metrics
- Adhere to safety and compliance requirements
Minimum Preferred Qualifications: Skills
- Excellent oral and written communication skills
- High level of proficiency in Microsoft Office (Word, Excel, Outlook)
- Acute attention to detail
- Ability to coordinate multiple projects/tasks while still delivering high quality results under time constraints
- Strong organizational and project administration skills
- Excellent oral and written communication skills, and ability to successfully interact with key internal stakeholders and clients
- Experience working in a GxP environment preferred
- Familiarity with NetSuite
Education/ Experience:
- Bachelor's degree in life science, business administration, or related field with not less than four (4) years’ experience in a biotechnology project management or related field; or
- Masters’ degree in life science, business administration, or related field with not less than two (2) years’ experience in a biotechnology project management or related field
- Knowledge base in science with the relevant regulations for our industry
- Proficient in project management software (smartsheet preferred)
Supervision Received:
- Infrequent supervision and instructions
- Frequently exercises discretionary authority
Position Type and Expected Hours of Work:
- This is a full-time, 4-month contract position at 40 hours per week
- This role is not eligible for benefits
- Occasional weekend, holiday, and evening work required
Working Environment:
- Primarily office environment
- Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
Physical Demands
- Ability to work in an upright and/or stationary position for up to eight (8) hours per day
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office equipment
- Occasional mobility needed
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
- Light to moderate lifting and carrying (or otherwise moving) objects, including office supplies and laptop computer, with a maximum lift of 20 pounds
- Ability to access and use a variety of computer software
- Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
- Frequently interacts with others to obtain or relate information to diverse groups
- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; requires multiple periods of intense concentration
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
- Ability to perform under stress and multi-task
- Regular and consistent attendance
Skills Required
- Bachelor's degree in life science, business administration, or related field with at least four years' experience in biotechnology project management or related field; OR Master's degree with at least two years' experience
- Proficient in project management software (Smartsheet preferred)
- High level of proficiency in Microsoft Office (Word, Excel, Outlook)
- Strong organizational, project administration, and resource planning skills
- Excellent oral and written communication skills and stakeholder/client interaction
- Attention to detail and ability to manage multiple projects under time constraints
- Knowledge base in science with relevant industry regulations (GxP familiarity)
- Experience working in a GxP environment
- Familiarity with NetSuite
What We Do
BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development. With laboratory locations in North Carolina’s Research Triangle Park; Cambridge, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of therapeutics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e., product release testing, stability testing, etc.) BioAgilytix also offers diagnostic testing services at its CLIA-certified, CAP-accredited Boston laboratory. BioAgilytix’s team of highly experienced scientific and QA professionals ensures high-quality science, data integrity and regulatory compliance through all phases of clinical development. BioAgilytix is a trusted partner to many top global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.
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