Tango Therapeutics

Tango Therapeutics

Clinical Contract Manager

Boston, MA

Sponsorship not specified$129k-$193kDetected 36 days ago
GCPComplianceNegotiationForecastingFDA RegulatoryResearchCommunicationCollaborationSarbanes-Oxley

About the role

  • Serve as Sponsor key contact for CRO functions involved in Clinical Trial Agreement (CTA) development, negotiation, execution and maintenance.
  • Facilitate communication and collaboration between internal and external contributors (e.g., Legal, GDPR, Finance, Clinical Trial Team (CTT) members).
  • Organize and coordinate meetings with key stakeholders, including decision tracking and action item follow-up.

Responsibilities

  • Develop site contracting plan in line with approved budget and fair market value.
  • Manage CTA review and approval by internal contributors (e.g., Legal, CTL).
  • Support investigator budget forecasting, accrual processes, and reconciliation.
  • Identify risks and issues related to contracting plan and lead the development and implementation of mitigation strategies and action plans.
  • Manage accurate and up-to-date CTA information in systems and communication tools.

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.
  • Experience in outsourcing and oversight.
  • Familiarity with clinical trial systems (e.g., CTMS, eTMF) and operational metrics, KPIs, and KRIs.
  • Knowledge in ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines.
  • participate in internal audits and regulatory inspections, as required.
  • Ensure ongoing inspection and audit readiness of CTAs; participate in internal audits and regulatory inspections, as required.
  • Direct experience with site health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred).
  • Familiarity with site contracting requirements and healthcare compliance (Fair Market Value, SOX Act, Sunshine Act)
  • #LI-Hybrid
  • We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status
  • Salary range
  • $128,800 - $193,200 USD

Nice to have

  • Experience in Oncology development (preferred).

Compensation

  • $128,800 - $193,200 USD

Visa & Work Authorization

  • Serve as Sponsor key contact for CRO functions involved in Clinical Trial Agreement (CTA) development, negotiation, execution and maintenance.
  • Keep Sponsor Legal informed of site activation plan and priorities.
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