Senior Site Contracts Specialist

Talanto; Northern (KY); Hybrid; USD 88,000 - 207,000; Full time

Job summary

Talanto is seeking a Senior Specialist, Site Contracts to draft, negotiate and execute clinical site agreements across regions. The role supports the Site Contract Lead and mentors junior staff within Study Start Up and Regulatory.

It requires substantial CSA negotiation experience with strong regulatory and project-management skills. Candidates should have a degree in business, law, or life sciences, and a proven ability to manage multiple contracts, meet deadlines, and maintain country

Qualifications

• Undergraduate or graduate degree in business, law, or life sciences or equivalent combination of education and experience.
• Extensive experience in negotiating CSAs and Investigator grants (preferably above 4 years).
• Good knowledge of applicable regulations, drug development and clinical project management procedures.
• Good understanding of country requirements pertaining to Site Contracts delivery in the Americas.
• Remarkable attention to details and ability to meet deadlines.
• Excellent interpersonal skills and ability to work proactively.

Responsibilities

• Draft, negotiate, finalize, and execute clinical site agreements and amendments at country or regional level.
• Track progress of Site contracting activities during Study Start Up or Maintenance.
• Escalate issues with clear rationale and contingency plans to mitigate impact.
• Collaborate with Site Contracts Lead and other stakeholders to achieve project goals.
• Provide SME guidance on CSA elements for assigned studies and maintain country intelligence.
• Support local regulatory and quality processes within the Study Start Up framework.

Skills

CSA negotiation

Investigator grants

Regulatory knowledge

Contracting

Project management

Education

Undergraduate or graduate degree in business, law, or life sciences

Job description

Important: if an employer asks you to log into their system via iCloud or Google, send a code, an SMS or Telegram password, run some code, or install software — refuse. These are signs of fraud.

The Senior Specialist, Site Contracts will manage the site contracting process locally or across a region
in support of assigned projects by drafting, negotiating, finalizing and execution clinical site
agreements, ancillary agreements or amendments during study startup or maintenance. The Senior
Specialist, Site Contracts will also support the Site Contract Lead as a local subject matter expert in all
matters related to Site contracts in countries or region of assignment and may act as a mentor to more
junior staff within the Study Start Up and Regulatory Department. The Senior Specialist, Site Contracts
may also lead Site Contracting activities on a study level.

ROLE AND RESPONSIBILITIES

• Responsible for drafting, negotiating, finalizing, and executing clinical site agreements,ancillary agreements as well as amendments at country or regional level, in accordance with
• project requirements and country regulations, and within the projected delivery timelines
• Tracks in a timely manner progress of Site contracting activities during Study Start Up or
• Maintenance and provides clear rational for delays, as well as a contingency plan to mitigate their impact, and escalates any issues as soon as identified.
• Collaborates with the Site Contracts Lead, project management, clinical management, and clinical operations personnel to achieve project goals.
• Responsible for creating a predictable project delivery experience for both study teams and clients alike.
• Acts as country or regional subject matter expert for all such CSA elements on assigned studies for internal and sponsor stakeholders alike and ensures country intelligence is up to date in country intelligence repositories.
• Undergraduate or graduate degree in business, law, or life sciences
  or equivalent combination of education and experience.
• Extensive experience in negotiating CSAs and Investigator grants (preferably above 4 years)
• Good knowledge of applicable regulations, drug development and clinical project management procedures.
• Good understanding of specific country requirements pertaining to Site Contracts delivery in the Americas
• Remarkable attention to details
• Ability to work proactively and effectively to meet project
  deadlines.
• Good interpersonal skills
• Resilience and ability to manage multiple tasks, set priorities and adapt in changing work assignments.
• Ability to exercise sound judgement and to make decisions
  independently

When you join Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

Quality: we hold ourselves to the standard patients deserve.

Integrity and trust: we do the right thing, especially when it is hard.

Drive and passion: we care about the outcome, because someone is waiting on it.

Agility and responsiveness: we move quickly, because patients cannot wait.

Belonging: everyone is welcome, and every voice counts.

Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.

U.S. Hiring Locations:

#LI remote

Medicine moves forward here. So will you.

is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.

We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality and the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait.

That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow their careers and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance, because good science comes from people who feel supported.

If you want work with purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.

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