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.

The Associate Director (AD), Data Integration and Clinical Business Administration is responsible for leading data integration initiatives and overseeing the Clinical Business Administration. This role involves managing the integration and administration of various data solutions to enhance business processes across Clinical Pharmacology and Global Clinical studies and ensure efficient data handling supporting critical business processes such as deviation tracking, site payments, study actions, decisions, and issues, quality events, and clinical monitoring. Working on a study-by-study basis, the AD understands how the study EDC is set up and how subject data is collected for each study. Additionally, the AD ensures the CBA team supports the study team directly through the administration of CTMS builds, including study setup, trip report templates, and problem investigation.

Summary of Responsibilities:

• Lead the strategy and development of the data integration and clinical business admin capabilities.

• Manage both the Data Integration team and the Clinical Business Admin (CBA) team and ensure they are effectively delivering on their project commitments on time and on budget.

• Make assignments to team members based on new studies started up in Veeva CTMS

• Ensure the CBA team supports the study team directly through administration of CTMS builds, including:

• Support system administration and project issue escalation.

• Create and update study details in UCV and Siebel CTMS.

• Update trip report templates

• Maintain CBA job aids.

• Evaluate and adjust CBA procedures.

• Ensure Data Integrations from study EDC systems are created and supported for every study which includes :

• Collaborate with study team to build and support data mappings throughout each study.

• Map study data for ingestion to downstream systems like CTMS, oversight, monitoring, and grant management tools.

• Ensure all study solutions maintain a validated state. Validate integrations connecting EDC to downstream systems.

• Participate in grant payment kick-off and troubleshooting meetings.

• Lead IT ticket reconciliation for missing data. Lead data issue troubleshooting and re-pulls of data for IT ticket management for missing data.

• Provide technical support and guidance for issue resolution.

• Serve as the Subject Matter Expert (SME) for data flow across key Fortrea systems.

• Collaborate across the organization to implement projects including members from clinical PM, the iGPS Team, DMs, and Xcellerate Teams to ensure correct mappings and ongoing operational support and troubleshooting.

• Manage the evolution of proprietary processes and technology frameworks for data integrations.

• Support audits concerning data integrations.

Qualifications (Minimum Required):

• Bachelor’s degree.

• Strong understanding of the life sciences industry.

• Veeva Admin certification.

• Experienced Oracle Siebel Developer.

• Experience with ETL workflows.

• Understanding of grant payments workflows and functionality, including grant payment budgets and support.

• Client-facing experience (internal and external clients).

• Expertise in Rave Webservices and ODM calls.

• Experience with annotated eCRF and listings mapping.

• Proficiency in Oracle APEX for flat file mapping.

• Expertise in Excel Power Query (Quick Base) customization.

• Exceptional analytical, strategic thinking, and problem-solving skills.

• Excellent communication and interpersonal skills, capable of working effectively with cross-functional teams.

• Leadership qualities that inspire team confidence and respect while motivating team members in a creative and effective manner.

Experience (Minimum Required):  

• At least 5+ years of experience in management roles within the life sciences or software development industry.

• Expertise in metadata mapping.

• Administration experience with Veeva UCM and Siebel CTMS.

• Proven track record of leading successful technology projects.

Preferred Qualifications Include:

• Advanced degree (MBA or equivalent).

• Demonstrated ability to think creatively and strategically when solving problems and making decisions.

• Leadership and interpersonal skills, with a focus on empathy and building collaborative relationships.

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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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