TrialSpark is a technology company that brings new treatments to patients faster by reimagining the clinical trial process.Today, a clinical trial can cost more than $100M and take 10 years to complete, bottlenecking the development of new treatments for patients. We’re fundamentally changing how trials are run, rethinking the trial process both from a technology and operational perspective.

Job Description

Our Quality Assurance (QA) team at TrialSpark is looking for its first IT compliance manager. This role is critical to TrialSpark’s core business of running a clinical trial site network and Contract Research Organization activities.

Your responsibilities will include:

• Author, and review computer system validation documentation, including validation plans, risks assessments, IQ/OQ, URS/FRS, PQ, test scripts, trace matrix, final summary reports for analytical instrumentation ensuring GxP and data integrity requirements are maintained.
• Review and approve periodic reviews of qualification and computer system validations ensuring compliance with the qualified/validated state of the system(s). Ensure appropriate remediation plans are identified for gaps identified during the periodic reviews.
• Facilitate the schedule with various department leads with the scheduling of PQ testing.
• Execute test scripts associated with administrative activities.
• Facilitate change controls for implementation and retirement of instrument/equipment.
• Prepare documentation and provide support for regulatory inspections and inspection readiness activities.
• Ensure department SOPs adhere with Corporate Policies, Corporate Procedures, and regulatory expectations.

Relevant Experience:

• BS in a related field or similar.
• 5+ years of working IT compliance in the pharmaceutical or biotech industry.
• Deep IT domain and technology knowledge
• Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility.
• Must have knowledge of good documentation practices, GxP, regulatory requirements for computerized analytical systems validation (i.e. 21 CFR part 11) and disaster recovery. GCP and CFR Part 11 and Data Integrity and privacy regulations experience a plus.
• Interpersonal, oral and written communication skills are essential.
• Must contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.