Clinical Trial Manager

Major Duties & Responsibilities

• 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
• Serve as the primary sponsor-side unmasked contact for unmasked investigative site personnel
• 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 repetition of duties and responsibilities

Qualifications

• Education: B.A./B.S. degree
• Experience: 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting clinical trial management
• 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
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
• Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work)