Senior Clinical Trials Manager

Summary

Join our Clinical Development Team as a passionate and collaborative Clinical Trial Manager to support the successful trial execution of Generate:Biomedicines's growing clinical portfolio.

Requirements

• Bachelor’s degree required; an advanced scientific degree is strongly preferred
• Minimum of 6 years experience within clinical trial operations at a sponsor company
• Candidate must have 3-4 years of independently managing clinical studies
• Experience in various therapeutic areas is needed
• Experience in CRO, vendor and laboratory oversight is required
• Motivated self-starter who is capable of flourishing in a fast-paced environment
• Creative problem solver with excellent communication and public speaking skills Strong interpersonal and organizational skills are needed, with a high degree of attention to detail
• Ability to interact well with individuals at all team levels (e.g., Clinical scientist, Program/Portfolio Managers, Physicians, etc.) and collaborate cross-functionally
• Ability to travel for up to 10% of time, both domestic and international
• Detailed knowledge of GCP. Knowledge of other relevant global regulatory requirements (ie FDA, EMA, and MHRA) is a plus
• Proficient in Microsoft Office (excel, word, Outlook, PowerPoint), electronic data capture (EDC) software, and other platforms related to electronic Trial Master File (eTMF) and Safety Reporting

Responsibilities

• Independently manages the operational aspects of Generate Biomedicines’ clinical trials, including vendors (CROs, central labs, etc.), global clinical trial sites, and cross-functional study teams
• Clinical Study Team Meetings: Leads cross-functional internal study team meetings and meets study deliverables in accordance with study timelines. Attends project team and/or executive team meetings as required
• Oversees the identification, qualification, and selection of clinical trial sites and investigators alongside CRO including management of key relationships
• Leads development of Request for Proposal (RFP) process for new vendors and organizes the cross-functional study team to attend bid defense meetings and complete scorecards prior to selection
• Clinical Study Execution: Oversees, manages, and serves as the point of contact for the successful execution of one or more early-stage clinical trials Manages clinical study budgets, execution timelines, identification of issues and risks to study timelines. Ensures adherence to study timelines and project and program goals
• Manages all clinical operations vendors contracted for the assigned studies (including respective vendor invoicing and budgets)
• Organizes investigator meetings, kick-off meetings, monitoring training, and various CRO (and other external stakeholder) meetings
• Reviews and authors pertinent sections of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, study manuals, and recruitment materials
• Ensures timely execution of study deliverables, performance management, risk management and issue resolution
• Reviews site/study reports and metrics to ensure timely collection of clinical data, samples, and lab results
• Develops action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs
• Maintains and oversees the electronic Trial Master File for assigned studies
• Clinical Study Site Engagement: Cultivates and maintains strong relationships with investigators and trial site administrators Supports/attends clinical site initiation visits, monitoring (and monitoring oversight) visits, and site closeout visits with effective collaboration with CRO, Investigators, and site staff on any outcomes/findings
• Authors/Collaborates on SOP development and implements standardized clinical business tools
• Participation in the preparation of presentations of trial data for internal and external parties (management review, scientific meetings, and advisory boards)
• Trains and mentors junior clinical operations staff
• Leads inspection readiness preparedness activities for study and closely collaborates with the Quality leads to update IR trackers

Benefits

COVID Safety: Generate:Biomedicines enforces a mandatory vaccination policy for COVID-19. All employees must be fully vaccinated and have received a booster