Responsibilities

• Expert in conducting peer reviews for others and validation of project deliverables within the team.
• Independently maintains a strong understanding of the latest industry trends and technologies with regard to Data Science.
• Expert in developing and delivering training for internal and external stakeholders regarding Data Science processes and deliverables.
• Strong understanding of CROs and/or Health Systems and the drug development process.
• Expert in developing requirements and specifications from analysis of business needs.
• Expert in preparing, correcting, modifying, and analyzing data sets using complex analytic techniques
• Strong experience mentoring others, both technical and non-technical, toward a better understanding of data science methodologies and results.

Requirements

• Retina Experience 
• College graduate in Data Science or similar discipline, or related experience, Masters or PhD preferred.
• Ability to anticipate and effectively resolve potential problems with client demands.
• Demonstrates managerial skill and experience.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problem-solving skills.
• Good organizational and communication skills.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.

Responsibilities

• Responsible for all aspects of study site monitoring, including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
• Responsible for all aspects of site management as prescribed in the project plans
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data

Requirements

• Retina Experience 
• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
• In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered.

Responsibilities 

Plans and directs schedules as well as project budgets. Monitors the project from inception through delivery. May engage and oversee the work of external vendors. Assigns, directs and monitors system analysis and program staff. These positions’ primary focus is project/program management rather than the application of expertise in a specialized functional field of knowledge although they may have technical team members.

Requirements

• PMs: 3+ years of clinical trial experience in pharmaceutical, biotech or CRO, including at least two (2) years in retina
• Sr PMs: 5+ years in clinical operations, data management or related discipline in CRO or pharmaceutical industry to include people management
• Project Director: 7+ years in clinical operations, data management or related discipline in CRO or pharmaceutical industry to include people management
• Working understanding of GCP/ICH guidelines and the clinical development process
• Ability to drive and availability for domestic and international travel including overnight stays
• Proven computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS)