Associate Manager, Clinical Research

Fortrea Development India Private Limited; São Paulo; Vor Ort; BRL 250.000 - 420.000; Vollzeit

Zusammenfassung

Fortrea Development India Private Limited is seeking a country-level Clinical Operations Lead to oversee local trial activities with a strong focus on regulatory compliance and quality. You will build relationships with investigators, vendors and external partners while coordinating cross-functional teams to achieve country commitments.

The role requires deep clinical research knowledge, leadership skills, and the ability to navigate ICH/GCP requirements across multiple sites and stakeholders in

Qualifikationen

• University/college degree in life sciences or related allied health field.
• At least 4 years of clinical research experience in pharma or CRO.
• Solid knowledge of ICH Guidelines and GCP and regulatory requirements.
• Understanding of the drug development process.
• Fluent in local language and English (written and spoken).

Aufgaben

• Accountable for performance and compliance for assigned protocols in country.
• Proactively drive and track execution and timelines to meet country commitments.
• Manage budgets and contracts as delegated; forecast country resource needs.
• Oversee quality and compliance; supervise CRAs and CTMCs; training.
• Collaborate with investigators and external partners; site validations and recruitment.
• Collaborate with PV, Regulatory, GMA/GHH; align with regional operations.
• All other duties as needed.

Kenntnisse

English fluency

Communication

Time management

Leadership

Multi-tasking

Attention to detail

Discretion

Ausbildung

Life science degree

Nursing certification

Medical or clinical laboratory certification

Jobbeschreibung

Job Overview:

- The aCRM is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client in compliance with ICH GCP and country regulations. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives, especially during the study. Significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements in countries. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives. As a customer-facing role, this position will build business relationships and represent Client with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships. Requires ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director or Therapeutic Director. Requires strong understanding of local regulatory environment, country regulations, client policies and procedures, quality standards. Strong scientific and clinical research knowledge is required for this position. A strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously. Requires skills to effectively build and maintain professional relationships with investigators and other external stakeholders, requiring strong communication, educational/pedagogic, diplomatic and empathic skills. The role will require proven ability to collaborate and lead high performing cross-functional teams also in a virtual environment. The position requires strong leadership skills (scientific and business) and ability to coordinate and lead local teams to high performance. Oversee country commitments, compliance and training needs. Additionally, business leadership and alignment with corporate requires that individual has ability to lead across several dimensions simultaneously. Works collaboratively with Country and Regional Operations; Pharmacovigilance, Regulatory, Global Medical Affairs and Global Human Health internally; and with external functional outsourcing vendors. Requires coordination and alignment with the regional and broader organization. Additionally, will work to build and maintain relationships with investigators and other external partners and promote Client’s reputation. In collaboration with CRD, represents Client in Pharma industry issues and in seeking influence in external R and D environment.

Summary of Responsibilities:

• - PERFORMANCE - Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally. 30%
• - MANAGEMENT - POC for assigned protocols. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated). 20%
• - QUALITY OVERSIGHT - Responsible for quality and compliance in assigned protocols in country. Oversees CRAs and CTCs on assigned projects. Oversees training compliance. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed. Oversees associate CRMs assigned to the Client and work on training needs in collaboration with functional vendor 20%.
• - EXTERNAL CUSTOMER FACING - Responsible for collaboration with functional outsourcing vendors, investigators, and other external partners. Oversees country and site validations, site selection and recruitment in assigned protocols. Responsible for clinical trial education to sites. Country POC for programmatically outsourced trials for assigned protocols.20%
• - INTERNAL COLLABORATION and STRATEGY - Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. 10%
• - All other duties as needed or assigned.

Qualifications (Minimum Required):

• - University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
• - In lieu of the above requirement, candidates with a minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered.
• - Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
• - Thorough understanding of the drug development process.
• - Fluent in local office language and in English, both written and verbal.
• - Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• - Focus on Customer – Manager
• - Innovate and Change – Manager
• - Pursue Scientific and Process Excellence – Manager
• - Work with Others – Manager
• - Achieve Results – Manager

Experience (Minimum Required):

• - Good organizational and time management skills.
• - Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
• - Excellent communication skills, oral and written.
• - Self-motivation with the ability to work under pressure to meet deadlines.
• - Works well independently as well as in a team environment.
• - Detail and process oriented.
• - Positive attitude and approach.
• - Interact with internal and external customers with a high degree of professionalism and discretion.
• - Multi-tasking capability.
• - Good computer skills with good working knowledge of a range of computer packages.
• - Ability to lead and develop junior staff.
• - Flexible and adaptable to a developing work environment.
• - Minimum of six-eight (6-8) years of clinical research experience.

Physical Demands/Work Environment:

Client office as per assignment.

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