Senior Clinical Trial Manager

The Role: 

Generate Biomedicines is searching for an enthusiastic and collaborative Senior Clinical Trial Manager to join our Clinical Development Team. This role will report into the Director, Clinical Operations and will work closely with Data Management, Clinical Supply, Regulatory Affairs, and Preclinical Discovery & Development on all late stage trial execution efforts related to our COPD program.  The Senior Clinical Trial Manager will lead the startup, execution, and closeout efforts for Generate’s clinical studies in alignment with organizational and program goals. This role is also responsible for the management of clinical study budgets, timelines, and vendors, as well as the mentorship of junior team members. The successful candidate will be highly organized and detail oriented, possess great communication skills, and a willingness to collaboratively develop process and departmental standards. 

Here's how you will contribute:

• Independently manages the operational aspects of Generate Biomedicines’ clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites, specifically late stage needs in Asthma/COPD. 

• Leads cross-functional internal study team meetings and meeting deliverables. 

• Identification, qualification, and selection of clinical trial sites and investigators alongside CRO including management of key relationships. 

• Leads day-to-day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs and central labs. 

• Facilitates investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings. 

• Development and review of specific study documents e.g. informed consent forms, study guidelines, operations manuals, training materials. 

• Participation in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials. 

• Management of clinical study budgets and execution timelines. 

• Ensures adherence to study timelines and project and program goals. 

• Attends and leads monitoring oversight visits and effective collaboration with CRO, Investigators, and site staff on any outcomes/findings. 

• Reviews study reports and metrics to ensure timely collection of clinical data, samples, and lab results. 

• Collaboration on SOP development and promotion of standardized clinical business tools. 

• Development of action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs. 

• Maintenance and oversight of Trial Master File for assigned studies. 

• Collaborate with QA and cross functional teams to ensure inspection readiness activities for assigned clinical trials, ensuring TMF completeness, audit preparedness, and compliance with GCP, SOPs, and applicable regulatory requirements. 

• 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 staff 

The Ideal Candidate will have:

• Bachelor’s degree required. Advanced scientific degree is preferred 

• 8+ years of experiene in clinical operations, with at least 4+ years in late stage trial operations with a sponsor company 

• Experience in various therapeutic areas (Respiratory indications a strong plus) 

• Experience in CRO, vendor and laboratory oversight is required 

• Motivated self-starter who is capable of flourishing in a fast-pac