Clinical Project Manager
Intralytix is seeking an Associate Clinical Project Manager to work (full-time, in-office) at our company headquarters in Columbia, Maryland. The successful applicant will work independently, reporting to the Director of Clinical Development, to meet company goals and manage our Sponsored clinical trials and associated activities. This role is responsible for multiple aspects of clinical trial performance, including study start-up, document generation/review, and TMF management/reconciliation. He/she/they will contribute to decisions supporting clinical trial design and execution and ensuring Intralytix’s regulated products comply with applicable regulatory and industry standards for biological products for clinical, food safety, veterinary, probiotic and/or cosmetic applications.
Duties & Responsibilities:
Works with the Clinical Project Manager and/or Director of Clinical Development, and cross-functional project teams and Sites by assisting with tasks, including:
- Full-cycle project management: Manage execution of multiple clinical projects through various stages of development, from protocol development to CSR, to ensure timely trial activation, conduct and closeout.
- Ensure study compliance with all ICH/GCP, SOP and regulatory requirements.
- Coordinate deliverables and timelines of cross-functional teams and partners.
- Provide and/or ensure GCP and study-specific training for the clinical research staff.
- Oversee junior associates and/or assist senior management, CTCs, PIs, and monitors in general clinical operations duties as requested.
- Ensure all study information and documents are maintained and in compliance with study protocols, ICH/GCP, SOP and regulatory requirements.
- Coordinate activities of study monitors.
- Develop plans and risk mitigation strategies to ensure successful delivery of study goals.
- Perform a variety of research, database and clerical duties of a complex and technical nature in support of clinical trial operations, including maintaining and updating integrated master schedules, organizing, attending and documenting meetings and/or visits.
- Regularly draft, review and/or update clinical/laboratory/monitoring plans, manuals, SOPs, ethics committee/regulatory documentation, source documents, study reports, policies and processes to ensure all quality standards are in compliance with GLP/GCP standards, FDA/EMA/ICH and other applicable regulations and requirements.
- Oversee eTMF generation, maintenance, and audits ensuring compliance with FDA/ICH regulations.
Required Skills & Technical Expertise:
- Previous experience with Phase 1 and 2 trials essential.
- In depth knowledge of GCP, FDA and ICH regulations/guidelines for IND clinical trials and industry best practices.
- Understanding of core technical, scientific and medical terminology.
- Familiarity with eTMFs, eBinders, EDCs and/or other global electronic systems.
- Experience with preparing and filing regulatory documents, selecting, activating and managing research/clinical sites, preparing work scopes, budgets, and study plans.
- Working knowledge of IND safety reporting.
- Clinical Trial Monitoring experience is a plus.
- Experience supporting federal government contracts or grants is a plus.
Education & Previous Eexperience:
- Applicable clinical or project management certifications are preferred.
- B.S. in a Life Sciences or related discipline and 5+ years of relevant clinical experience in biotech/pharma – OR –
- M.S. in a Life Sciences or related discipline and 3+ years of relevant clinical experience in biotech/pharma.
- 2+ years of full-service clinical project management experience.
- Experience within the life sciences industry, preferably biologics, biotechnology or pharmaceuticals, however medical devices is acceptable as well, performing within a clinical research role with prior project management experience.
The salary will be commensurate with experience and qualifications. The benefits package includes health insurance, company paid life insurance and long-term disability insurance, and 401(K) with matching company contribution.
Please send a cover letter with a summary of experience, curriculum vitae, and the names and contact information of at least two references to:
Dr. Jennifer Schwartz
8681 Robert Fulton Dr.
Columbia, MD 21046.
Applications also can be e-mailed to email@example.com. No phone calls please.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. At the present time, Intralytix, Inc. is unable to support visa applications; therefore, all applicants must be already eligible for employment in the United States. Intralytix, Inc. is an equal opportunity employer.