Job Overview:
The CRM 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, 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 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.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- 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.
- Focus on Customer.
- Innovate and Change.
- Pursue Scientific and Process Excellence.
- Work with Others.
- Achieve Results.
Experience (Minimum Required):
- Minimum of six-eight (6-8) years of clinical research experience.
- 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 team environment.
- Detail and process oriented.
- Positive attitude and approach.
- Interact with internal and external customers with 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.
Preferred Qualifications Include:
- 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.
- Minimum of six-eight (6-8) years of clinical research experience.
- 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 team environment.
- Detail and process oriented.
- Positive attitude and approach.
- Interact with internal and external customers with 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.
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
- Thorough understanding of the drug development process.
- Focus on Customer.
- Innovate and Change.
- Pursue Scientific and Process Excellence.
- Work with Others.
- Achieve Results.
Physical Demands/Work Environment:
- Client office as per assignment.
- Travel Requirements:
- ≤ 20-40 % travel may be required.
- International and Domestic Travel may be required, including overnight stays as necessary consistent with project needs and office location (this will vary based on country and project needs).
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