Clinical Contract Manager

Posted 15 Days Ago
Be an Early Applicant
Boston, MA, USA
In-Office
129K-193K Annually
Senior level
Biotech
The Role
The Clinical Contract Manager will oversee the clinical site contracting process, ensuring compliance and timely execution of Clinical Trial Agreements while collaborating with various stakeholders.
Summary Generated by Built In

Company Overview 

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. 

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. 

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. 

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts. 

Summary

We are seeking a Clinical Contract Manager (CCM) to lead the end-to-end clinical site contracting process in support of our growing clinical portfolio. This role will serve as the primary sponsor contact for Contract Research Organization (CRO) partners and internal stakeholders across Clinical, Legal, Finance, and Compliance. 

In a fast-paced, small biotech environment, the CCM will drive the development, negotiation, execution, and maintenance of Clinical Trial Agreements (CTAs), ensuring alignment with trial timelines, budget, and regulatory requirements. This individual will play a key role in enabling timely site activation, CTA maintenance as per trial requirements, proactively identifying and mitigating risks, and ensuring compliance of CTAs with applicable regulations and internal standards. 

The ideal candidate is highly collaborative, detail-oriented, and comfortable operating in a hands-on environment, with a focus on building scalable processes, tools, and best practices to support efficient and compliant clinical trial execution.

Your 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.
  • Contribute to development of templates, training material, and playbook.
  • Develop site contracting plan in line with approved budget and fair market value.
  • Align with Clinical Trial Leader (CTL)/ Clinical Trial Manager (CTM) and/or Site Management Leader (SML) on site activation plan and priorities.
  • Oversee and track end-to-end CTA workflow and report progress to CTL/ CTM and/or SML.
  • Identify risks and issues related to contracting plan and lead the development and implementation of mitigation strategies and action plans.
  • Manage CTA review and approval by internal contributors (e.g., Legal, CTL).
  • Manage accurate and up-to-date CTA information in systems and communication tools.
  • Train external contributors (e.g., CRO functions involved in CTA process).
  • Participate in CTT meetings and CRO meetings, as needed.
  • Keep Sponsor Legal informed of site activation plan and priorities.
  • Ensure CTA compliance with applicable regulations (e.g., SOX compliance, Sunshine Act, and Fair Market Value).
  • Support investigator budget forecasting, accrual processes, and reconciliation.
  • Ensure ongoing inspection and audit readiness of CTAs; participate in internal audits and regulatory inspections, as required.

What You Bring 

  • 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 Oncology development (preferred).
  • Direct experience with site health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred).
  • Experience in outsourcing and oversight.
  • Familiarity with clinical trial systems (e.g., CTMS, eTMF) and operational metrics, KPIs, and KRIs.
  • Familiarity with site contracting requirements and healthcare compliance (Fair Market Value, SOX Act, Sunshine Act)
  • Knowledge in ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines.

 #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

Skills Required

  • 5+ years of trial management experience
  • 3+ years in site management
  • Bachelor's degree in Life Sciences, Pharmacy or related field
  • Experience working in a global clinical development organization
  • Direct experience with site health authority inspections
  • Experience in outsourcing and oversight
  • Familiarity with clinical trial systems (CTMS, eTMF)
  • Familiarity with site contracting requirements and healthcare compliance
  • Knowledge in ICH-GCP and FDA guidelines
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Boston, Massachusetts
157 Employees
Year Founded: 2017

What We Do

Tango Therapeutics is a biotechnology company discovering and developing novel medicines targeting cancer vulnerabilities to deliver transformational new therapies for patients. Tango was launched in 2017 with a $55 million Series A investment from Third Rock Ventures. The company has established a robust product engine that leverages advances in DNA sequencing and CRISPR-based target discovery to generate breakthrough medicines that have the potential to provide deeper, more sustained benefit than today’s targeted therapies, and extend the benefit of available immuno-oncology agents. Tango Therapeutics is focused on three areas of drug development, each in well-defined patient populations currently lacking effective treatment options, and each with hallmarks of cancer that have not been targeted yet. These include: loss of tumor suppressor gene function; multiple oncogenic drivers; and immune evasion. What fuels each of Tango’s programs is an increasingly sophisticated ability to utilize synthetic lethality - the interaction between two genes that causes cell death when both are inactivated. In cancer cells, one of these genes is inactivated by mutation; the other will be inactivated by a drug. This approach leaves normal cells largely unaffected, with the potential to greatly enhance anti-tumor efficacy and reduce associated toxicity. Tango’s success will be driven by its depth of understanding of the genetic subtypes of cancer, and corresponding insights into novel drug targets and combinations uniquely relevant to each subtype. By shaping discovery efforts in this way, Tango has the potential to reach the clinic quickly, and with a clear plan for identifying the patients most likely to benefit from each new treatment, an approach that could increase both speed and probability of success in translating novel target discoveries into transformational new medicines for patients.

Similar Jobs

Liberty Mutual Insurance Logo Liberty Mutual Insurance

Solutions Architect

Artificial Intelligence • Fintech • Insurance • Marketing Tech • Software • Analytics
Hybrid
Boston, MA, USA
40000 Employees
137K-257K Annually

Liberty Mutual Insurance Logo Liberty Mutual Insurance

Data Engineer

Artificial Intelligence • Fintech • Insurance • Marketing Tech • Software • Analytics
Hybrid
Boston, MA, USA
40000 Employees
83K-154K Annually

People Inc. Logo People Inc.

Art Director

AdTech • Consumer Web • Digital Media • eCommerce • Marketing Tech
Remote or Hybrid
US
3500 Employees
80K-100K Annually

CarGurus Logo CarGurus

Systems Administration II

Consumer Web • eCommerce • Software
Hybrid
Boston, MA, USA
1200 Employees
84K-105K Annually

Similar Companies Hiring

Formation Bio Thumbnail
Artificial Intelligence • Big Data • Healthtech • Biotech • Pharmaceutical
New York, NY
140 Employees
SOPHiA GENETICS Thumbnail
Software • Healthtech • Biotech • Big Data • Artificial Intelligence
Boston, MA
450 Employees
Pfizer Thumbnail
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
New York, NY
121990 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account