Clinical Trial Manager (Retina)

Trial Management

Serve as the primary unmasked contact for managing protocol execution, including oversight of the unmasked CRO, other study service providers, and consultants that are involved in a clinical trial.

Support unmasked drug supply and accountability activities including oversight of IWRS system.

Act as the unmasked liaison between Clinical Operations and Clinical Supply.

Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs.

Avoidance of repetitive tasks: Ensure clinical trial documentation such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study level documents are prepared and reviewed.

Ensure the unmasked Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews.

Proactive identification and support for development of plans and resolution of project issues, participation in process improvement initiatives as required.

Conduct unmasked study specific training of CRO study staff, monitors, investigational sites, and service providers.

Perform and manage IP data review process on an ongoing basis.

Oversee outsourced monitoring by reviewing unmasked monitoring reports to ensure quality and resolution of site-related issues.

Ensure tracking and review of protocol deviations and assesses impact on study data.

Develop and manage study budget and maintain within financial goals; Reviews and approves clinical invoices against approved budget.

Provide oversight for forecasting of clinical supplies, including study drug and supplies.

Department Management

May manage and/or oversee work of junior Clinical Operations staff.

Support development and review of Clinical SOPs and other department initiatives.

Qualifications

• Education: B.A./B.S. degree in Science
• Experience: 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting a retina clinical trial
• Global APAC experience desired
• Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
• Strong clinical study management skills
• Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners
• Proven clinical operational skills to direct protocol execution to ensure timeline, budget and quality metrics are met
• Excellent communication skills to effectively disseminate information to project team and outside parties
• Experience reviewing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management
• Clinical research knowledge and cross-functional understanding of clinical trial methodology
• Excellent organizational, conflict resolution, prioritization and negotiation skills
• Proven ability in creative problem-solving and exercising sound judgment
• Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners
• Ability to handle a high volume of highly complex tasks within a given timeline
• Develop Therapeutic Areas knowledge and expertise through internal training and external conference attendance
• Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook
• Working knowledge of MS Project for development and update of clinical study timelines
• Physical Requirements and Working Conditions: Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).