Senior Manager, Study Management
Franklin Biolabs · King of Prussia, PA, US ·
- Seniority
- Senior
- Employment
- Contract
- Category
- Management
Franklin Biolabs emerges from the esteemed legacy of Dr. Jim Wilson's laboratory, a beacon of innovation in vector technology for over three decades. Building on this rich heritage, Franklin Biolabs is poised to redefine the landscape of the global genetic medicines industry. As a Contract Research Organization (CRO), Franklin Biolabs offers a comprehensive suite of services spanning from discovery through clinical manufacturing. Our goal is to empower our partners by providing unparalleled solutions that drive the advancement of genetic medicines. Leveraging decades of expertise and a commitment to excellence, we bridge the gap between groundbreaking research and ensuring that transformative therapies reach those who need them most.
Franklin Biolabs, Inc. is in search of a Senior Manager, Study Management, who has responsibility for the management of study-related activities conducted by the In Vivo Services team. The Senior Manager, Study Management, will ensure that all animal-related study activities are fully supported in a timely, efficient, and effective manner. The Senior Manager, Study Management will ensure that operations are conducted in accordance with USDA, DEA, OLAW, GLP, and AAALAC standards.
Specific responsibilities include, but are not limited to:
- Directly supervise a dynamic team of Study Scientists, providing daily oversight, mentorship, and performance management
- Ensure staff are trained in study techniques, animal models, and regulatory practices, to ensure your team is well-prepared to conduct studies in compliance with established protocols and regulatory standards
- Develop and revise operational procedures and methods for study support, including contribute to process improvement initiatives by helping to develop and refine internal procedures aimed at increasing efficiency, consistency, and scientific quality
- Study sample collection and delivery for non-GLP and GLP studies with managerial / quality control (QC) oversight and ensuring compliance with ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate)
- Review and edit study protocols to ensure clarity, feasibility, and compliance
- Collaborate with other teams within Franklin Biolabs to ensure study completion
- Develop and track reviews of standard operating procedures (SOPs) to ensure compliance
- Participation in regulatory audits and inspections as a subject matter expert (SME) as required
Education and Experience
- Minimum of Associates Degree with AALAS accreditation or BS/BA degree in Life Sciences, Animal Science or related field required.
- 5+ years of direct experience in the laboratory animal field (10+ years preferred)
Certifications or Licenses:
- AALAS Certification at LATG level or higher preferred
- AALAS Accreditation required if individual holds Associates Degree only
Knowledge, Skills and Abilities:
- Knowledge of regulatory compliance and agencies (USDA, DEA, OLAW, GLP, AAALAC).
- Knowledge of animal care and use and regulatory expectations.
- Strong analytical and organizational skills.
- Strong interpersonal skills with the ability to influence and negotiate through conflicting situations.
- Self-directed individual with the ability to perform in a fast-paced environment with limited direction, competing priorities under tight deadlines.
- Ability to communicate clearly and effectively, both verbally and in writing, to interact with team members, clients, vendors and other third parties.
- Ability to collaborate effectively with individuals across various disciplines to ensure alignment.
- Ability to use digital communication tools (video conferencing, chat platforms etc.) to effectively collaborate with team members in hybrid and remote settings.
Travel:
- Ability to travel domestically and/or internationally up to 5% of the time, depending on the needs of the project, the client and the company.
- Ability to accommodate evening, overnight or weekend travel, including potential extended trips to attend training, meetings, conduct fieldwork, or meet with clients.
On-Site:
- This position requires full-time on-site presence at our Discovery Labs location.
Immunizations and Screenings:
- This position will require working with animals (e.g. Nonhuman Primates, Rabbits, Rats, Mice).
- This position requires access to lab spaces.
- This position will require access to lab animal spaces.
Essential Status:
- Essential for Closure: This position may be required to go on-site during company closures to sustain the life and care of animals/biological materials. Examples of company closures include snow days, special shutdowns, etc.
- Potential inclusion in weekend and/or holiday rotation.
Vision:
- Ability to distinguish between different colors (normal color vision).
- Ability to see clearly at various distances.
- Adequate near vision for reading documents or lab equipment.
- Ability to focus and maintain concentration in tasks for extended periods.
- Ability to work in environments with varying light conditions.
Company Benefits:
- 401(k)
- 401(k) Matching
- Health insurance
- Dental insurance
- Vision insurance
- Health Savings Account and Flexible Spending Account
- Paid Time-Off
- Company Paid Holidays
- Personal Floating Holidays
- Short-Term and Long-Term Disability
- Life and AD&D insurance (Group & Voluntary)