Please note that this is a 1 year contract position.
The Clinical Project Leader will independently plan and provide oversight for activities in clinical development to support the validation of assigned assays. He/she will drive results through his/her focused and disciplined approach to clinical development that is consistent with best practices in the industry. He/she will work collaboratively with product management, regulatory, and R&D teams to design, execute and deliver clinical programs.
• Lead the design and execution of consented and non-consented sample collection studies and laboratory testing activities to support the validation of biomarkers for in vitro diagnostic assays and to support assay product development, regulatory market application submissions of new or reformulated IVD products or additional indications. Independently plan and execute clinical studies.
• Lead and oversee internal and external sample collection, testing activities and assigned resources. Review and monitor ongoing clinical, medical and diagnostic assay data and conduct periodic onsite or remote monitoring of clinical sites to ensure protocol adherence, data integrity and regulatory compliance. Ensure compliance of program conduct and study documentation practices consistent with relevant laws, regulations and guidelines, and company policies and procedures.
• Manage the transfer of incoming and outgoing materials in the biorepository, the handling of potentially biohazardous materials including blood, body fluids and other tissues from various sources, data management of the data associated with the specimens including support of the clinical study logistics (sample fulfillment, shipments, randomization and labeling). Plan, acquire and deploy instruments and study materials for clinical studies.
• Lead and coordinate internal and external clinical cross-functional project teams to ensure that the clinical program effectively supports the overall assay product development program objectives within approved budgets and committed timelines. Manages external partners and oversees outsourced work.
• Write or supervise the writing of study protocols and study reports or summaries. Prepare and present clinical design proposals and submission review responses to regulatory authorities to ensure adequacy of support for all claims pertaining to safety, efficacy, and clinical performance.
• Identify and select Principal Investigators, external service providers, sample collection sites and testing sites. Prepare study agreements and external service provider, sample collection site and testing site budgets.
• Monitor study costs and coordinate/track payments. Manage clinical project expenses within approved budget. Assist in preparation of training documents and study materials. Train/assist in training of Principal Investigators, study sites, CROs and vendors.
• Bachelor or higher degree required in a biological science (medical technology, clinical laboratory science, microbiology, infectious diseases, immunology, biochemistry, or closely related science).
• Minimum of 5 years direct clinical study research experience, with a minimum of 2 years IVD assay/instrument experience.
• Clinical Laboratory Scientist Certification, MT (ASCP) or equivalent preferred
• Certified Clinical Research Associate (CCRA) preferred
• Experience with diagnostic laboratory methods
• Experience managing FDA 510k, PMA, BLA clinical programs and international registrations preferred
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES (MINIMAL COMPETENCIES)
• Familiarity with validation requirements for obtaining CE-IVDR and/or FDA clearance/approval of In Vitro Diagnostic (IVD) products
• Basic statistical knowledge
• Knowledge of regulations and standards (CFR, GCP, ICH, ISO, etc.) affecting IVDs and Biologics required
• Proven oral and written communication skills
• Proven planning skills; ability to create and track detailed project plans (MS Project)
• Proven interpersonal, leadership and organizational skills & effective time management
• Ability to work independently and within a cross-functional team environment to analyze and solve problems, and to make sound decisions
• Strong interpersonal and negotiating skills
• Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates
Applicants must provide their phone number. Reference job number A835.