SearchLocation
Home > United States > Texas > San Antonio > legal

Director, Contracts and Budgets


Director, Contracts and Budgets

Director, Contracts and Budgets

Evolution Research Group
San Antonio, TX 78229

Job details

Job Type

Full-time
Job Title:
Director/Sr. Director, Contracts and Budgets
(depending on experience)


Job Description:

ERG is the largest independent clinical research site services company focused on special populations and is the market leader in CNS. With 20 wholly owned clinical sites, we conduct in-patient and out-patient phase I-IV clinical research studies. Our mission is to provide the highest quality execution of clinical trials in all clinical research phases aimed at helping sponsor companies to get their life saving or life enhancing drugs to market as quickly and safely as possible.

The Director, Contracts and Budgets is responsible for the overall management of study related agreements across all ERG owned clinical trial facilities and network sites. In executing these position responsibilities, the Director, Contracts and Budgets is guided by applicable FDA regulations, Good Clinical Practices (GCP), International Committee on Harmonization (IHP) guidelines, and company standard operating procedures and policies.

*Remote Role*

Responsibilities:

  • Drafting, negotiating, and finalizing agreements and amendments for various clinical projects.
  • Draft investigator grants for RFPs and awarded studies based on adequate scope of work, clinical trial protocol
and other clinical trial information.
  • Establish, when appropriate, master service agreements with sponsors.
  • Develop and negotiate rate cards for MSAs as required.
  • Determine potential needs for contract amendments and manage amendment execution.
  • Analyze clinical trial agreements and identify areas of concern and/or contention and draft appropriate counteroffer language.
  • Contracting for early development services including contracting for CRU to manage the CRO services.
  • Escalate contract and/or budget issues appropriately.
  • Assume responsibility for tracking and reporting of contract documents.
  • Adhere to corporate and ethical guidelines.
  • Contribute to improving processes and establish refinements that reduce cycle time, create savings and
improve efficiency in the contracting process.
  • Collaborate with corporate team and site staff to ensure proper dissemination and management of
knowledge and to meet defined goals and objectives.
  • Attend project team meetings as required.
  • Periodically attend professional conferences and/or webinars
  • Review professional publications

Skills and Qualifications:
  • College degree preferred, commiserate experience will be considered.
  • Approximately 7-10 years of experience negotiating site contracts, developing Investigator grants and RFPs.
  • Pharma and CRO experience preferred; site experience a plus
  • Understands FDA regulations, as well as Good Clinical Practices (GCP) and International Conference
on Harmonization (ICH)guidelines.
  • Able to communicate with co-workers, sponsors, site staff and others in a collaborative and courteous manner.
  • Experience presenting in front of sponsors and CROs, colleagues, and site staff.
  • Demonstrates the initiative to act independently, initiating activity as required and making appropriate decisions
within the constraints of the regulations, guidelines and company policy.

Competencies:
  • High level of contract management experience with strong knowledge of legal and contracting parameters.
  • Experience working with sponsor organizations and contract research organizations is essential.
  • Excellent negotiation, documentation, and leadership skills, as well as strong team-orientation and interpersonal skills.
  • Excellent written/oral communication and organization skills.
  • Customer focus with ability to manage challenging priorities and remain flexible and adaptive in stressful situations.
  • Experience managing a group.
  • Excellent Computer Skills to include: Word, Excel, PowerPoint, as well as proprietary applications unique to the
clinical research industry. Emphasis on Excel proficiency.


Hiring Insights

Hiring for this role


• Mobile: NA

• Location: NA

• Post ID: 21440334


Related Ads (See all)


Home | My Account | Contact | Privacy | Terms | Free Classifieds | Free ads
bedpage is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2022  bedpage