Biopharma Study Manager, Clinical Operations

About Saga Diagnostics:
Saga Diagnostics is a precision oncology company focused on developing and delivering cutting-edge molecular diagnostic solutions. We partner with biopharmaceutical companies to advance oncology research, clinical trials, and personalized treatment approaches.

Job Overview
The Biopharma Study Manager will serve as a critical project manager and primary point of contact for biopharma clients, overseeing the execution of clinical trials that utilize Saga Diagnostics’ advanced molecular diagnostic assay. This role ensures studies are delivered on time, within scope, and in compliance with regulatory and quality standards.

The Biopharma Study Manager will work closely with internal teams across clinical operations, quality assurance, client services, and biopharma business development to ensure compliance at each phase of the product development lifecycle — from research-use-only (RUO) labeling through investigational use (IUO). This position requires a collaborative, detail-oriented professional with a strong understanding of clinical trial processes and regulatory pathways (GCLP, CLIA, 21 CFR Part 812).

Key Responsibilities
Study Management:
• Oversee biopharma-sponsored studies, ensuring efficient planning, execution, and delivery.
• Develop and manage project plans, timelines, and budgets to meet client and organizational objectives.
• Coordinate internal and external study teams, including investigators, vendors, and laboratory teams.
Cross-Functional Collaboration:
• Partner with clinical operations, quality assurance, client services, and biopharma business development teams to ensure study success.
• Act as a bridge between internal teams and biopharma clients, facilitating smooth communication and operational alignment.
Regulatory Compliance:
• Ensure adherence to GCLP, CLIA regulations, 21 CFR Part 812, and other relevant standards.
• Maintain compliance at each phase of the product lifecycle, from RUO to IUO, as needed for study success.
• Collaborate with regulatory and quality assurance teams to ensure study-related documentation and activities meet all applicable guidelines.
Client Engagement and Support:
• Serve as the primary liaison between Saga Diagnostics and biopharma partners.
• Provide clear communication of study progress, timelines, and deliverables to clients.
• Work collaboratively with clients to address study-specific needs and ensure alignment with regulatory requirements.
Operational Oversight:
• Oversee study documentation, including protocols, informed consent forms, and regulatory submissions.
• Work closely with laboratory teams to ensure proper labeling, handling, and analysis of samples under RUO and IUO conditions.
• Monitor data accuracy and ensure timely reporting to meet client and regulatory expectations.
Quality Management:
• Ensure compliance with internal quality systems and external regulatory requirements.
• Support audits and inspections, ensuring adherence to GCLP, CLIA, and FDA standards.

Requirements

• 5+ years of experience managing clinical studies in the biopharma or diagnostics industry.
• Solid understanding of GCLP, CLIA laboratory-developed tests (LDTs), and 21 CFR Part 812 regulatory requirements.
• Proven ability to ensure compliance across different phases of product development.
• Strong project management skills with a track record of delivering on timelines and budgets.
• Exceptional communication and interpersonal skills for cross-functional collaboration and client engagement.

Preferred:
• Experience working with oncology diagnostics or molecular testing, such as PCR, NGS, or liquid biopsy assays.
• Familiarity with regulatory submissions, including IDEs and PMAs.
• Knowledge of biopharma industry trends and study lifecycle requirements.

Key Competencies
• Expertise in regulatory frameworks (GCLP, CLIA, FDA).
• Strong organizational skills and attention to detail.
• Ability to collaborate effectively with diverse internal teams and external partners.
• Proactive problem-solving and a focus on results.

Education:

• Bachelor’s degree in a life sciences discipline (e.g., biology, biochemistry, molecular biology).

Benefits

• Contribute to innovative solutions that improve cancer care.
• Join a team that values collaboration, innovation, and dedication to advancing precision oncology diagnostics.
• Competitive salary, membership in SAGA’s equity scheme, flexible working arrangements, and a dynamic startup culture with regular team events.
  
  SAGA Diagnostics is an equal opportunity employer, fully committed to achieving a diverse and inclusive workplace that embraces and encourages applicants of every background.  The company’s policy regarding equal employment opportunity means that all decisions regarding recruitment, hiring, benefits, wage and salary administration, scheduling, disciplinary action and termination will be made without unlawful discrimination on the basis of sex, gender, race, color, age, national origin, religion, disability, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, citizenship status, pregnancy or maternity, veteran status, or any other status protected by applicable federal, state or local law. If you require reasonable accommodation in completing an application, interviewing, or otherwise participating in the employee selection process, please direct your inquiries to hr@sagadiagnostics.com.