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Generate Biomedicines

Pioneering generative biology to create breakthrough therapeutics.

Senior Clinical Trial Manager

Clinical ResearchClinical ResearchFull TimeRemoteSeniorTeam 201-500Since 2020H1B SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

2 days ago

Salary

$140K - $196K / year

Seniority

Senior

Bachelor Degree8 yrs expEnglishGoogle Cloud Platform

Job Description

Senior Clinical Trial Manager

Generate Biomedicines

• 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.

Job Requirements

  • 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-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.)
  • Ability to travel for up to 30% 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.

Benefits

  • Competitive benefits package
  • Annual bonus
  • Equity compensation

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