Basic Function and Scope of the Position:
Provide the clinical department with technical assistance in the development of diagnostic products and collaborations as part of the global Reproductive Health and Genomics programs. Provides technical oversight on projects related to sequencing and/or new technologies for the successful conduct of clinical studies and collaborations consistent with applicable regulations, guidelines and procedures (where applicable). Reviews, assesses and interprets data from ongoing and completed studies/collaborations. Conducts clinical compliance activities and will be assigned to multiple projects concurrently.
Tasks and Responsibilities:
- Providing technical assistance related to sequencing on ongoing and new projects related to the clinical program.
- Oversight and monitoring of clinical lab compliance with appropriate guidance, regulations and/ or policies.
- Responsible for the successful management of multiple projects and collaborations in parallel from start up through study completion on time and on budget.
- Other task (Quality discordance) and other responsibilities are required.
- Leads clinical lab sub-teams and reports sub-team activities to core team.
- Manages activities performed by consultants, CROs and vendors including initial identification of a suitable partner, definition of responsibilities, preparation of communication plan, defining division of responsibility, monitoring of milestones and budget, review of monthly status reports, and interactive management of CRO to ensure project success.
- Reviews, assesses and interprets data from ongoing and completed studies, and prepares reports as required. Support the writing of abstracts, papers, and manuscripts related to study results as required.
- Participates in the conduct of internal and external audits and inspections of clinical programs.
- Participates in the development of clinical strategies and development plans for products in development.
- Creates and implements departmental procedures (including helping define the Clinical Quality system and SOPs) in compliance with industry standards and regulatory requirements.
- Perform other duties as assigned
Preferred Educational Background:
- Bachelor’s degree or equivalent in the life sciences or related field required; advanced degree (Master’s or above) preferred.
Preferred Experiential Background:
- 8+ years of industry experience; vitro diagnostic or quality engineering a plus
- Data management experience highly desirable.
- Knowledge of statistical principles as applied to clinical trials highly desirable.
- Thorough knowledge of GCP, GLP, ICH guidelines and other US and international clinical regulatory requirements.
- Demonstrated ability to work independently with new, complex technologies and produce professional work products.
- Strong written and verbal communication skills; demonstrated ability to organize and present scientific information (e.g., clinical study results) to internal and external audiences.
- Strong work ethic and demonstrated ability to deliver assignments on time.
Equal Opportunity Employer
Illumina, Inc. - 6 months ago
Illumina elucidates the human genome. The firm makes tools used by life sciences and drug researchers to isolate and analyze...