Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Associate Site Contract Leader

Company: PAREXEL
Location: Paris, Île-de-France,France
Reference: 47585BR
Closing Date: 08 Jan 19
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

• 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. ...

Requirements:

• 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
thecountry 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
tolocal 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 tomanage
/ 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
assurequality 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)
Qualifications

  • 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 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).
Minimum Work Experience
  • Experienced CRA, CMA, CTS or a person with a legal or business degree or other relevant experience, preferably in one of the following environments: Contracting, Clinical Operations, Legal (Paralegal) or in a comparable function in another CRO or pharmaceutical company
  • 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 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).
Minimum Work Experience
  • Experienced CRA, CMA, CTS or a person with a legal or business degree or other relevant experience, preferably in one of the following environments: Contracting, Clinical Operations, Legal (Paralegal) or in a comparable function in another CRO or pharmaceutical company

Apply for this job: Associate Site Contract Leader

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
England
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site
Advertisement

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.