Student Programs Manager
Prompt Therapy Solutions Inc
Senior Site Contracts Manager
ERGOMED
full-time
Posted on:
Location Type: Remote
Location: Remote • North Carolina • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Oversees negotiations of clinical study agreements (CTAs) on a study level and drives CTA document finalization and execution, including contractual language & terms, financial attachments, and investigator grant budgets
- Provides oversight of contact & budget negotiations status and manages escalation of out-of-parameter queries on budgetary and contractual requests to sponsor decision-makers.
- Provides consultation during escalation of out-of-parameter queries as needed.
- Plan the Clinical Site Agreement (CSA) execution strategy for assigned studies in line with overall study start-up delivery plans and client expectations.
- Work closely with internal and external stakeholders to prepare the necessary Clinical Site Agreement templates, payment terms, as well as fallback positions and negotiation parameters in line with Ergomed’s standards.
- Lead CSA negotiations on a study level and drive the finalization and execution of CSAs as per planned timelines.
- Create and maintain document status reports’ and update department tools/systems and team members on a regular basis; Ensure appropriate documentation is maintained by Ergomed staff assigned to the contracting process.
- Manage site and study level discussions with internal and sponsor team stakeholders around fair market value of investigator budgets and payment terms within corporate and industry standards during negotiation with sites.
- Establish strong working relationships and collaboration with Sponsor to ensure smooth negotiations and repeat business with Ergomed.
- Be accountable for Site Contracts delivery of assigned projects and/or initiatives.
- May oversee people management activities including interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counselling
- Perform other work-related duties as assigned.
Requirements
- BS degree in law, business, life sciences, a health-related field, or equivalent combination of education and experience.
- Strong CRO operational experience with a track record of success in Site Contracts Management working in an international or global capacity.
- Thorough knowledge of applicable regulations, drug development and clinical project management procedures.
- Understanding of the specific country/ sites requirements pertaining to Site Contracts delivery in North America
- Good presentation, documentation and interpersonal skills.
- Proficient in MS Office (Word, Excel and PowerPoint), outlook and Internet.
- Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
- Attention to attention to detail, effective oral/written communication skills along with the ability to work independently to meet deadlines.
- Strong leadership skills; ability to teach/mentor lesser experienced team members.
Benefits
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical study agreementscontractual languagebudget negotiationsclinical site agreementsinvestigator grant budgetsdocument status reportssite contracts managementdrug developmentclinical project managementregulatory knowledge
Soft skills
interpersonal skillspresentation skillsdocumentation skillsattention to detailoral communicationwritten communicationleadership skillsmentoringtime managementcollaboration
