Clinical Project Manager - Sponsor Dedicated (Fsp)

IQVIA Inc; São Paulo; On-site; BRL 110,000 - 160,000; Full time

Job summary

IQVIA is seeking a Clinical Project Manager – Sponsor Dedicated to lead local trial management efforts in Brazil. You will oversee budgets, ensure compliance with ICH-GCP and local regulations, and coordinate with country teams to meet enrollment targets.

The role requires a health/science degree, 2+ years of trial management experience, and strong communication in English and the local language. Travel may be required as part of the responsibilities.

Qualifications

• BA/BS degree.
• Degree in a health or science related field.
• Minimum of 2 years of local/regional trial management experience in the pharmaceutical industry or CRO and previous experience as Clinical Research Associate.
• Specific therapeutic area experience may be required depending on the position.
• Strong working knowledge of ICH-GCP, company SOPs, local laws and regulations, assigned protocols and protocol specific procedures.
• Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home according to business needs.
• Excellent decision-making and strong financial management skills.
• Proficient in speaking and writing the country language and English.

Responsibilities

• Adheres to Sponsor SOPs, WIs, policies, and GCP regulations.
• Prepares or contributes to high level budget estimates and detailed proposals.
• Acts as primary country contact and monitors project progress and recruitment to meet targets.
• Maintains trial management systems and reports; assists with HA inspections and audits.
• Contributes to site recruitment strategy and local contingency planning.
• Reviews country-specific informed consent forms and assists with protocol-related procedures.

Skills

Budget management

ICH-GCP

Trial management

Regulatory compliance

English proficiency

Local language proficiency

Education

BA/BS degree in health or science

Job description

Clinical Project Manager – Sponsor Dedicated. Clinical Project Management services provide management of a clinical trial (s) in a local level. Services/deliverables include operational oversight of assigned project(s) at the local level for end-to-end project management from start-up through to closeout activities.

Tasks & Responsibilities:

• Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements.
• Prepares or contributes to high level budget estimate in response to Request for Service’s followed by detailed budget proposal. Ensures overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
• Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
• Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits. Escalates corrective and preventive actions (CAPA) to GTL MAO and CPL when the trial deviates from plans and communicates study progress and issues to study management teams and business partners.
• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Contributes to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates. This includes reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.

Essentials Requirements:

• BA/BS degree.
• Degree in a health or science related field.
• Minimum of 2 years of local/regional trial management experience in the pharmaceutical industry or CRO and previous experience as Clinical Research Associate.
• Specific therapeutic area experience may be required depending on the position.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
• Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home according to business needs.
• Excellent decision-making and string financial management skills.
• Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.