Join the Versiti Clinical Trial Services Team

Location: Quantigen LLC, Fishers, Indiana (On-Site Only)

Employment Type: Full-Time (40+ Hours/Week)

Summary: Quantigen, Part of Versiti Clinical Trial Services, is seeking an accomplished scientific Project Manager. The Project Manager will provide comprehensive oversight and coordination for clinical research projects from concept through close-out. This role requires proactive planning, rigorous documentation, and cross-functional collaboration to ensure successful execution in compliance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, applicable regulatory requirements, and Quantigen’s quality standards. The Project Manager will serve as the central point of communication between sponsors, internal teams, and external partners, ensuring that all stakeholders are aligned, timelines are met, and deliverables are achieved.

Qualifications

• Bachelor’s degree in life sciences, healthcare, or related field (advanced degree preferred).
• Minimum 2 years of project management experience in a CRO or clinical research environment.
• Demonstrated knowledge of clinical trial processes, GCP, ICH guidelines, and regulatory requirements.
• Proven track record in managing multiple complex clinical studies simultaneously.

Non-Technical Qualifications:

• Exceptional organizational and documentation skills, with a detail-oriented approach.
• Strong leadership, interpersonal, and communication skills.
• Proficiency in project management tools (e.g., MS Project, Smartsheet, Streamtime, etc.) and Microsoft Office Suite.
• Ability to manage shifting priorities, mitigate risks, and meet deadlines.
• Analytical mindset with ability to monitor performance and project metrics.
• High level of comfort managing multiple projects and their associated teams of personnel.
• Excellent communicator, capable of cogently presenting data to clients and internal stakeholders in both written and oral form.

Responsibilities

Project Planning & Execution

• Define, develop, and implement a roadmap for new projects covering all phases—concept, launch, execution, and close-out.
• Maintain a comprehensive list of deliverable dates for each project.
• Create and update detailed Gantt charts (or equivalent) capturing milestones, deliverables, due dates, and responsible parties.
• Maintain a master schedule across all projects to optimize resource planning and meet deadlines.
• Select, develop, and implement supporting project management software to track timelines, progress, resource allocation, and budgets.

Stakeholder & Client Coordination

• Prior to project initiation, collaborate with Quantigen directors, trial sponsors, trial monitors, and regulatory partners (e.g., Pearl Pathways) to provide key clinical trial documents and clarify responsibilities, project status, risks, and issues.
• Serve as the primary point of contact for sponsors, principal investigators, and regulatory support personnel, ensuring protocol compliance and timely information exchange.
• Organize and document all communication with clients and support project teams as needed.

Progress Tracking & Communication

• Conduct weekly follow-ups with Technical Directors and other project leaders to review deliverables, address delays, and resolve project-level concerns.
• Regularly communicate project status to leadership and provide updates as requested.
• Attend project meetings (including those outside normal business hours), record and distribute detailed meeting minutes, and respond promptly to inquiries from sites and sponsors.
• Own and optimize portfolio operating mechanisms, including weekly program reviews.

Resource & Risk Management

• Interface with scientific leads for short-term and long-term resource allocation.
• Attend weekly meetings with Technical Directors and the Director of Laboratory Operations to adjust personnel assignments based on timelines and workload.
• Identify and manage potential risks across multiple projects, including acute issues related to resource allocation, and escalate concerns to leadership when needed.

Documentation & Compliance

• Maintain all study documentation and ensure proper saving and archiving throughout the project and at close-out.
• Ensure all projects adhere to GCP, ICH guidelines, SOPs, and applicable regulatory requirements.
• Stay informed about all current protocols at Quantigen.

Additional Duties

• Perform other duties as assigned to support project, departmental, or organizational goals.

Location: Quantigen LLC, Fishers, Indiana (On-Site Only)

Employment Type: Full-Time (40+ Hours/Week)

Summary: Quantigen, part of Versiti Clinical Trials Services, is seeking an accomplished scientific leader to serve as Director of In Vitro Diagnostics (IVD). This is a high-impact role with both technical and personnel management responsibilities, requiring daily, on-site engagement to ensure effective oversight of teams and projects.

Preferred Qualifications:

• Ph.D. in molecular biology or related field and/or a minimum of 8-10 years of relevant, hands-on experience in high-complexity laboratories. Master’s Degree will be considered.
• 2-3 years of experience closely supporting IVD device development efforts, either at a biotech or pharmaceutical company.
• Both project and personnel management experience are desired, as overseeing the design and successful execution of client-based IVD projects by junior scientists and technicians is a fundamental function of this role.

Technical Qualifications:

• A solid grasp of molecular and/or protein-based techniques – qPCR, sequencing, immunoassays, etc. – and associated instrument platforms, especially those commonly used in the field of in vitro / companion diagnostics.
• A thorough understanding of how to properly design, troubleshoot, and analyze experiments for measuring the performance specifications of molecular and protein-based assays, per CLSI / FDA guidelines.
• Experience with diagnostic assay and device development under design control to FDA and IVDR-compliant procedures, including SoPs constructed around ISO13485 guidelines.
• A working knowledge of the regulatory guidelines and documentation requirements for designing and executing clinical studies supporting eventual registration of in vitro diagnostics with the U.S. Food and Drug Administration (or equivalent oversight body). Experience with companion diagnostics is considered a major plus.

Non-Technical Qualifications:

• High level of comfort managing multiple projects and their associated teams of personnel.
• Excellent communicator, capable of cogently presenting data to clients and internal stakeholders in both written and oral form.
• Ability to meaningfully contribute to the combined efforts of multiple stakeholders to capture new business and successfully execute client-based projects.

Responsibilities

• The Director of In Vitro Diagnostic Development is responsible for both the technical and scientific oversight of developed platforms, workflows, and data analysis tools into the laboratory. Besides being present at the laboratory during scheduled work hours, this individual must be accessible as needed for on-site, telephone, or electronic consultation. Responsibilities will require cooperation and communication with Quantigen management (including the Chief Scientific Officer).

Additional duties include the following:

• Oversee and direct the daily activities of all junior personnel, as well as support their professional development goals through mentorship and other activities.
• Work collaboratively with internal stakeholders – finance, business development, scientists and lab technicians, project managers, regulatory specialists, quality team, and human resources, etc. –to always deliver exceptional service and support to our clients in a timely manner.
• Communicate with prospective clients to understand and delineate new project needs, as well as to estimate T&E costs
• Ensure personnel are appropriately assigned and have documented training to work on assigned projects
• Plan experiments for ongoing projects, reviewing results, and assisting others with technical troubleshooting
• Manage day-to-day activities of junior staff, and ensure compliance with all policies and procedures
• Communicate regularly with project managers, operations lead, CSO, and other relevant stakeholders about progress and issues
• Oversee daily progress of projects from both a technical and logistical standpoint
• Write and deliver final project reports (with data summaries) for the client
• Set performance goals and write annual performance reviews on all assigned personnel.

Additional Supervisory Skills:

• Excellent communication skills for effective listening and positive body language for giving feedback to employees and customers
• Good conflict resolution skills to improve organizational productivity
• Strong leadership skills to create a supportive and motivating work environment
• Good interpersonal skills to identify and establish a purposeful team culture
• Outstanding time and priority management skills to manage intense workloads and time constraints
• Problem-solving skills to solve problems effectively and choose suitable solutions.
• Ability to motivate employees
• Understand where to draw the line between personal and professional relationships in the workplace and enforce those same standards with subordinates

Location: Quantigen LLC, Fishers, Indiana (On-Site Only)

Employment Type: Full-Time (40+ Hours/Week)

Summary: Quantigen, Part of Versiti Clinical Trial Services, is seeking to hire a Laboratory Associate II.

The primary responsibility of this role will be:

• Design and execution of early-stage R&D projects
• Translation of assays and workflows from development into clinical deployment
• In vitro testing services on human subject samples, especially as part of device- and pharmaceutical-focused clinical trials

This position requires attention to detail, strong communication skills, and the ability to work independently in a regulated laboratory environment (e.g., FDA-compliant).

Other Key Responsibilities

• Perform molecular biology-based laboratory experiments
• Assist with writing SOPs, protocols, and test plans
• Analyze and interpret experimental data
• Present project updates using tools such as PowerPoint
• Maintain lab cleanliness and manage reagent/supply inventory
• Follow all laboratory safety protocols and procedures (BSL-2 environment)
• Work with human samples, including blood, urine, feces, and saliva
• Collaborate with coworkers and QA personnel to meet project timelines
• Other duties as assigned

Qualifications

• Bachelor’s degree in biology, molecular biology, biochemistry, or a related field
• At least 2 years of hands-on laboratory experience
• Comfortable working in a BSL-2 environment (training provided)
• Experience with next-generation sequencing (NGS) and/or Sanger sequencing preferred
• Proficient with Microsoft Word, Excel, and PowerPoint
• Strong attention to detail, organization, and problem-solving skills
• Effective written and verbal communication skills

Job Description

The Quality Compliance Advisor is responsible for creating, evaluating and remediating quality system to ensure compliance with federal regulation for devices and biopharmaceutical products. This role has the day-to-day responsibility for leading client projects to support product development, submissions, and post marketing activities. This individual must be detail oriented and possess good communication skills.

Responsibilities include:

• Evaluation of manufacturing facilities, labs, clinical sites, and contract research providers and quality units for compliance with current GXP US and global health authority regulations
• Develop quality assurance systems, SOPs, and plans to ensure companies are compliant and meeting business goals
• Execute internal, external vendor and mock audits to evaluate GCP, GLP and GMP for all phases of development for drugs and devices
• Conduct vendor assessments for quality standards and technical capabilities
• Development of and execution of training modules on Quality Systems
• Reports directly to the Director Quality/Regulatory

Training/Experience Requirements:

• At least 10 years drug OR device quality compliance experience. RAC or ASQ certification preferred.
• Bachelor’s degree required

Skills

• Strong technical background required
• Track record of leading quality system strategy and execution for either bio-pharma or device industry
• Both drug and device experience a plus.
• Mix of large sponsor company and small startup experience a plus
• Ability to work autonomously
• Exceptional communication skills, both verbal and written.
• For information regarding employment opportunities, or to apply to quality and regulatory positions, please send your resume to our careers team.

Job Description

The Regulatory Advisor is responsible for creating regulatory strategies, leading global health agency filings, and managing FDA communications on behalf of Pearl clients for devices and biopharmaceutical products. This role has the day to day responsibility for leading client projects to support product development, submissions, and post marketing activities.

Responsibilities include:

• Develop regulatory strategies for global submissions
• Lead regulatory submissions: IND, IDE, NDA, BLA, PMA, 510k, etc…and their global counterparts including CE Marks.
• Manage FDA and other global health authority face-face communications and via all other communication channels
• Write regulatory documents – for paper and eSubmission
• Lead cross functional teams across clinical, CMC, device engineering, quality, etc.. in gathering and authoring required information for submission
• Reports directly to Director of Quality/Regulatory

Training/Experience Requirements:

• At least 10 years drug OR device quality compliance experience.
• RAC certification preferred
• Bachelor’s degree required

Skills

• Strong technical background required
• Some experience in quality assurance roles or auditing preferred
• Track record of leading regulatory strategy and filings for bio-pharma and/or device industry
• Both drug and device experience a plus
• Mix of large sponsor company and small startup experience a plus
• Global filing experience preferred
• Ability to work autonomously
• Exceptional communication skills, both verbal and written