Site Contract Leader
Parexel
Parexel strives to be the premier provider to the biopharmaceutical and medical device industries for the development and commercialization of new medical therapies worldwide.
Headquartered near Boston, Massachusetts, Parexel operates in 82 locations in 51 countries around the world, and has 18,450 employees.
We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, integrated eClinical technologies, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.
Parexel's mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the biopharmaceutical and medical device industries in preventing and curing disease.
Headquartered near Boston, Massachusetts, Parexel operates in 82 locations in 51 countries around the world, and has 18,450 employees.
We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, integrated eClinical technologies, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.
Parexel's mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the biopharmaceutical and medical device industries in preventing and curing disease.
Parexel International Corp.
195 West Street
Waltham, MA 02451
195 West Street
Waltham, MA 02451
Site Contract/ Budget negotiation experience from CRO or Pharma is needed.
Regional/ Global experience is a plus.
This role can be fully remote base.
The main responsibility of the Site Contract Leader is the negotiation of study specific, generic, site
specific and country Clinical Site Agreements (CSA) and any other agreement that is required for the
completion of the Site Initiation Visit (SIV).
specific and country Clinical Site Agreements (CSA) and any other agreement that is required for the
completion of the Site Initiation Visit (SIV).
The Site Contract Leader is also responsible for managing
CSA activities and liaising with study specific stakeholders to ensure that the CSA start-up
deliverables are met.
Key Accountabilities
- Act as functional Leader on projects and develop study specific CSA strategy
- Drafting legal language and creating budgets for CSA negotiations
- Agree and negotiate study specific CSA templates with the Sponsor and Site as applicable
- Communicate CSA strategy, CSA turnaround timelines, tracking requirements and budget information/updates with key stakeholders.
- Coordinate interaction between Parexel study team and Sponsor as applicable to include but not limited to overall timeline management for CSA delivery.
- Provide updates about template amendments, process changes, investigator fees, local
- requirements etc. to ensure that relevant CSA database is maintained in real time
- Early recognition of areas of potential problems and formulate contingency plans
- Define solutions strategy of significant CSA changes requested by the site
- Participate in client and team meetings
- Identify and facilitate CSA training needs as applicable
- Maintain and assure quality of work generated
- Prioritize effectively and respond to urgent requests within team or sponsor lead
- Maintain a working knowledge of, and ensure compliance with applicable ICH-GCP
- Guidelines, local regulatory requirements, and Parexel SOPs and study specific procedures
- Complete routine administrative tasks in a timely manner (e.g. Timesheets, metrics, travel expense claims)The main responsibility of the Site Contract Leader is the negotiation of study specific, generic, site
specific and country Clinical Site Agreements (CSA) and any other agreement that is required for the
completion of the Site Initiation Visit (SIV).
Qualifications :
Minimum Work Experience
- 1-3 Years’ experience in site contract negotiation
Skills
- Possess strong negotiation, diplomacy, team leadership skills and excellent organizational
ability
- Excellent interpersonal, verbal and written communication skills
- Ability to motivate both individuals and a team.
- Ability to successfully work in a “virtual” team environment
- Must have strong analytical skills with the ability to create or interpret legal language and
budgets
- Demonstrate thought leadership and innovation
- Maintain grace under pressure while displaying a high level of professionalism
- Align internal and external resources to achieve objectives
- Attention to detail
- Work effectively as part of a team
- Comprehend and interpret contract language
- Identify problems independently and execute solutions
- Quickly comprehend desired end-result, goal or objective and act to accomplish
- Demonstrated effective decision-making
- Solid working proficiency of all MS Office Products specifically, Excel, Word, and PowerPoint
- Polished presentation skills
Education
- Degree in business, legal or life science or other relevant work experience in
Contracting, Clinical Operations or in Legal (Paralegal).
Language Skills
- Fluent in written and spoken English
#LI-REMOTE
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