Tango Therapeutics
Site Management Leader (SML)
Boston, MA
Sponsorship not specified$10k-$20kDetected 36 days ago
GCPProject ManagementVendor ManagementClinical TrialsFDA RegulatoryLeadershipCommunicationCollaborationProblem Solving
About the role
- Serve as the primary liaison between CTT and CRO for all site management activities
- Oversee CRO performance for site management to ensure compliance with contractual obligations, timelines, and quality standards
- Identify trial-level risks and contribute to the development and implementation of risk management and mitigation strategies
Responsibilities
- Manage and monitor site identification, feasibility assessments, and site selection processes
- Oversee and support site initiation visits (SIVs) and ensure timely site activation
- Collaborate with CRO to address site-level issues. Escalate unresolved issues to CTL and CTT, as needed
- Lead or contribute to the development of the Site Management Oversight Plan and other trial-specific operational plans in collaboration with CTT
- Contribute to the development of a site-related RBQM framework to drive efficiency and ensure quality of critical site management aspects
- Collaborate with CRO to address site-level issues.
- Leadership skills with the ability to lead cross-functional teams
Requirements
- 5+ years of trial management experience with 3+ years in site management.
- Bachelor's degree in Life Sciences, Pharmacy or related field
- Experience working in global clinical development organization
- Knowledge of ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines
- Knowledge of trial/ site risk assessment and management
- Experience in outsourcing and oversight
- Familiarity with clinical trial systems (e.g., CTMS, eTMF, EDC, IRT, eCOA) and operational metrics, KPIs, and KRIs
- Willingness to travel, as required (typically 10 - 20%)
Nice to have
- Leadership experience (preferred)
- Experience in Oncology development (preferred)
Compensation
- $128,000 - $192,000 USD
Benefits
- Direct experience with site health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred)
Visa & Work Authorization
- This role will be assigned to critical clinical trials of the Tango portfolio and serve as the primary contact between sponsor and CRO for site management aspects
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