Latest Jobs at QuintilesIMS

Job description

position can be based in Centurion, Cape Town or Bloemfontein

PURPOSE

Under general supervision, develop and prepare contracts for assigned customers, to support the Global sales team.

Responsibilities

• Work closely with project teams to determine appropriate terms and conditions of contracts
• Develop and prepare Contracts
• Act as primary customer interface on small to mid size projects
• Support senior team members on medium to larger customers / projects
• Revise or develop contract and related budgets and scope of work. Ensure the scope of work is defined correctly and budgets reflect the scope. Ensure any changes are integrated into the main study contract efficiently and accurately
• Assist in the negotiation of legal contracting text using Quintiles Global Contracting Policy, templates and fallbacks
• Oversee finalization and distribution of documents
• Update and maintain contract databases and files
• Perform all other duties as assigned
• All responsibilities are essential job functions unless noted as nonessential (N).

Required Knowledge, Skills And Abilities

• Knowledge of CRO Industry
• Knowledge of Microsoft Excel, Word and understanding of costing models
• Possess strong analytical skills and excellent verbal and written communication skills
• Ability to establish and maintain effective working relationships with coworkers, managers and customers

Did You Know?

• Quintiles helped develop or commercialize 98 of the Top 100 best-selling products of 2015
• Quintiles has 36,000 employees conducting business in more than 100 countries
• Quintiles was named to FORTUNE’s World’s Most Admired Companies® 2016 list
• Quintiles was named as a 2016 World’s Most Ethical Company® by the Ethisphere Institute

Minimum Required Education And Experience

• Degree in Life Science,
• Business Management or related field a
• A minimum of 1 year's direct experience in contracts or equivalent combination of education, training and experience

Physical Requirements

• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
• Occasional travel

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Job description

PURPOSE

Manage and perform tasks at country level associated with Regulatory, Start-Up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May participate in pre-award activities, proposals and oversights of the scope of work at country level.

Responsibilities

• Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines. Where applicable, act as a Country Lead for projects with no regional Lead assigned.
• Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Review, prepare and negotiate site contracts and budgets with sites.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
• May contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
• Assist in pre-award activities including bid defenses, proposals and oversights of the scope of work at country level.
• May support importation activities.
• May have direct contact with sponsors on specific initiatives.
• May act as Local Regulatory, Ethics and Contract Expert and reviewer of ICF.
• May act as mentor, and prepare and deliver country-specific training, for less experienced staff.
• May participate in feasibility and/or site identification activities.
• May perform Site Selection Visits if a trained monitor.

Did You Know?

• Quintiles helped develop or commercialize 98 of the Top 100 best-selling products of 2015
• Quintiles has 36,000 employees conducting business in more than 100 countries
• Quintiles was named to FORTUNEâs Worldâs Most Admired Companies® 2016 list
• Quintiles was named as a 2016 Worldâs Most Ethical Company® by the Ethisphere Institute

Required Knowledge, Skills And Abilities

• In-depth knowledge of clinical systems, procedures, and corporate standards
• Effective communication, organizational, and interpersonal skills
• Ability to work independently and to effectively prioritize tasks
• Ability to manage multiple projects
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• Knowledge of applicable regulatory requirements, SOPs and company’s Corporate Standards
• Understanding of regulated clinical trial environment and knowledge of drug development process
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Minimum Required Education And Experience

• Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or
• equivalent combination of education, training and experience.

Physical Requirements

• Extensive use of keyboard requiring repetitive motion of fingers.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.
• May require occasional travel.