Senior Business Process Specialist – Biospecimen

Location: Bay Area CA (On-site). This role will require traveling to the Santa Clara and Tucson offices.
Employment Type: Contract (W-2 Hourly or C2C).
Duration: 12 months. Possibility of renewal depending on personal performance and business needs.
Rate: $60 - $75/hr W-2 Hourly.

About Us
Concord isnt your typical consulting firm; we are an execution company with a passion for making things happen. Our mission is to help clients enhance customer experiences optimize operations and revolutionize their product offerings through seamless integration optimization and activation of technology and data.

We are purpose-built merging the industrys top specialty companies to amplify our Innovation Capabilities in analytics & AI data management & engineering UX and digital experience and technical platform integration automation & security engineering.

About the Role
We are seeking an experienced Process & Business Analyst with strong biospecimen management expertise to support the implementation and strategic adoption of a new Biospecimen Acquisition and Management platform across global molecular diagnostics teams.

This role requires someone who is comfortable engaging with senior leadership can operate strategically and is also able to get hands-on with process design requirements gathering documentation change management and stakeholder alignment. You will play a critical role in shaping how this new tool is used across the organization and influencing ownership and workflows moving forward.

Candidates must have hands-on inside-the-lab experience.

Key Responsibilities

• Own end-to-end biospecimen acquisition data management and/or biorepository management activities.
• Collaborate across global teams to ensure biological material needs are clearly defined documented communicated and met.
• Work closely with stakeholders including Procurement Legal Safety Quality and Imports/Exports.
• Participate in internal and external project meetings and provide regular updates.
• Maintain compliance with biospecimen processes and ensure accurate documentation.
• Manage information in validated Laboratory Information Management Systems (LIMS) in alignment with GxP standards.
• Identify and manage project issues risks and changing priorities.
• Support audit readiness for Safety Quality and Regulatory requirements.
• Leverage scientific expertise to influence decisions affecting project deliverables.
• Provide guidance mentorship and training to junior team members.

• Design plan and implement moderately complex sample acquisition strategies.
• Develop collection contracts and scopes of work.
• Monitor acquisition progress resolve discrepancies and maintain documentation.
• Ensure compliance with GCP GLP quality standards and ethical regulations.

• Manage biospecimen data transfers entry review validation and consistency checks.
• Work within validated databases ensuring accuracy and adherence to standards.
• Collaborate on data standardization initiatives.
• Act as a power user for key IT systems and support LIMS change cycles.

• Oversee biological material processing shipment inventory discrepancies and retrievals.
• Lead planning and execution of biorepository projects.
• Ensure compliance with permitting import/export and safety requirements.

Qualifications

• 5 years of experience in biospecimen acquisition biobanking clinical trial management interfacing with stakeholders and/or project management.
• Bachelors degree in a biological discipline or related field. A Masters degree in a biological discipline is highly desired.
• Experience in research diagnostics pharmaceutical CRO or medical device industry.
• Experience in the use of LIMS or other validated systems.
• Prior data management experience in the diagnostics pharmaceutical or medical device industry preferred.
• Experience with GLP/GCP requirements and awareness of the ethical considerations for the use of biological samples
• Self-motivated individual who can maintain quality accuracy and timeliness of deliverables.
• Strong interpersonal skills and the ability to build effective working relationships inside and outside their functional area
• Ability to work in a fast paced dynamic environment with efficiency; and capable of handling multiple projects.
• Good organizational written and verbal communication skills including excellent data handling skills meticulous proficient with MS Office and Google suite.
• Experience in handling biological specimens & willingness to work with potentially infectious biological material.
• Knowledge and skill in inventory management.
• Must be able to lift 30lbs work in a cold environment with limited daylight stand for long periods of time and climb ladders.

What We Offer (W2 Employment)

• Health Dental and Vision Insurance: Comprehensive coverage to support your overall well-being.
• Employer Contributions to Health Savings Accounts (HSA): For employees enrolled in High Deductible Health Plans Concord contributes toward your HSA.
• Flexible Spending Accounts (FSA): Options for healthcare and dependent care expenses plus a Lifestyle Spending Account (LSA) for wellness and personal development.
• Disability Insurance: Short-term (up to 12 weeks) and long-term coverage fully paid by the employer.
• Life and AD&D Insurance: Employer-provided coverage with options for additional voluntary coverage.
• Employee Assistance Program (EAP): Support for legal financial and personal challenges.
• 401(k) Retirement Savings: 1% employer match.
• Career Growth Opportunities: Pathways for advancement and skill development.
• Team Engagement Activities: Regular team-building events and company-sponsored activities to foster collaboration and connection.

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Concord is an execution partner helping organizations drive digital transformation modernization and scalable technology solutions. We deliver real results that solve real business challenges. We operate globally and are growing fast shaping the future of technology. Join a team trusted by top companies to drive strategic growth and operational excellence!