Job DescriptionThe 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.
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 specific country requirements pertaining to Site Contracts delivery in the Americas
- Remarkable attention to details
- Effective oral/ written communication skills
- 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
Additional InformationWhen you join Ergomed 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:
Florida, Georgia, South Carolina, North Carolina, Virginia, New York, Tennessee, Texas, Ohio,
#LI remote
