Site Contract Leader
- Employer
- Parexel - USA
- Location
- United States
- Salary
- Competitive
- Start date
- 4 Oct 2022
- Closing date
- 14 Oct 2022
View more
- Discipline
- Clinical Research, Clinical Trials Manager / Administrator
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
The main responsibility of the Site Contract Leader is managing the entire Clinical Site Agreement (CSA) process for a number projects, including the development of the study specific CSA strategy with the Sponsor, preparation of the corresponding country specific CSA templates and country specific budgets and also negotiation of such CSAs and budgets with the individual sites located in his/her region/country. Further, the responsibilities include managing CSA activities and liaising with PL, COL and the Sponsor to ensure that the CSA start-up deliverables are met.
Key Accountabilities
- Act as functional Leader on projects and develop study specific CSA strategy.
- Support site confidential disclosure agreements (Site CDA) negotiations, as required.
- Agree and negotiate study specific generic and/or country CSA templates and, subject to the input provided by other internal areas, negotiate the country budgets with the Sponsor.
- Gather relevant study information from PL/COL.
- Discuss and finalize specific country CSA templates with input from Sponsor, PL and/or COL, if appropriate
- Upon Sponsor approval of the country specific template, store the final approved and complete country CSA template and country budget in PMED, along with the corresponding CSA approval form.
- Arrange translations of CSA templates to local language.
- Prepare and negotiate with sites the respective CSA in accordance with the CSA strategy agreed with the Sponsor, CSA turnaround timelines, CTMS tracking requirements and budget negotiation parameters.
- Work within the defined “fallback” / approval parameters to manage / resolve significant CSA changes requested by the site
- Escalate changes that fall outside the documented “fall-back” parameters, if available, to the Sponsor, SCL line manager, or any other internal point of escalation, as appropriate and ensure that sufficient background information is supplied.
- Proactively keep PL/COL informed about CSA progress and any issues/challenges during the CSA negotiation.
- Maintain CSA negotiation status accurately tracked in CTMS
- Collect CSA signatures
- File fully executed CSA
- Maintain comprehensive language tracker
- Early recognition of areas of potential problems and formulate contingency plans
- Participate in client, investigator and team meetings, as required.
- 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)
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
- Ability to complete tasks in an accurate, timely manner and effectively manage multiple tasks
- Effective time management in order to meet daily metrics or team objectives
- Shows commitment to and performs consistently high quality work
- Ability to identify and address issues proactively in a timely manner
- Ability to take initiative, work independently and delegate
- Accountability for all assigned tasks
- Excellent computer and internet skills including knowledge of MS- Office products such as Excel, Word
Education
- Degree in business, legal or life science or other relevant work experience in Contracting, Clinical Operations or in Legal (Paralegal).
Company
Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.
Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.
Get job alerts
Create a job alert and receive personalised job recommendations straight to your inbox.
Create alert