This role is with one of our Ophthalmology Gene Therapy Clients, and supports the assigned Clinical Trial Lead with the design and execution of key elements of the Clinical Development Plan (clinical study or studies) with a minimal to moderate level of supervision. This includes activities relating to study design; data generation and validation; medical monitoring; and data analysis and interpretation. This position may support clinical development planning (collaboration with the Clinical Development Lead/Clinical Trial Physician for the provision and analysis of data to support future planning)
What You'll Do:
Support the design and writing of clinical protocols and associated clinical study documents (e.g. ICFs, charters, operational manuals, etc)
Serves as an expert on the clinical study design (including trial procedures and requirements) and develops training materials to ensure quality execution by the investigational sites.
Support cross-functional teams with study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures.
Engages clinical trial vendors to support study start-up activities in line with the clinical trial design
Either provide direct medical monitoring support or oversight of medical monitoring activities conducted by a CRO, which includes monitoring, cleaning, analyzing, and reviewing safety and efficacy data to establish the presence or absence of trends and follow up as appropriate
Collaborate on, or lead where appropriate, the writing of clinical and safety sections of key program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, Development Safety Update Reports, and other global regulatory submissions and responses.
Support clinical development planning by participating in the evaluation of innovative trial designs and provisioning and analyzing data from ongoing and/or completed clinical trials to support future planning
Maintaining awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
Who you are:
BS degree in a related discipline, higher-level degrees preferred.
5-7 years of experience in a clinical research-related role. 1-3 years experience in a Clinical science/development role preferred.
Proficient knowledge of GCP/ICH, drug development process, study design, statistics, understanding of functional and cross-functional relationships
Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
Knowledge of gene and ocular therapies preferred
Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
Previous experience in management of CROs and other vendors/suppliers preferred
Previous experience with Phase I-III US and Global/Ex-US study trials preferred
Excellent verbal, written, communication and interpersonal skills
Proficient in Medical Terminology and medical writing skills
Proficient critical thinking, problem solving, decision making skills
Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism
Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools