Local Study Manager Hematology - Fspx - Home Based Madrid

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

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.
This customer-facing role will build business relationships and represent Client with investigators, functional outsourcing partners and other external partners, significantly impacting country-level customer relationships.
Requires the 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, and 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.
Strong leadership skills (scientific and business) and the 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 the 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 the external R&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 the 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 works 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 & 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%
And 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):
MUST HAVE 2 / 3 years in the role and experience in Hematology AND Oncology Trials.
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.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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