The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Clinical Solutions Associate in Raleigh, NC.

Role Description

• Responsible for the oversight of clinical applications, system integrations, and data repositories. Systems may include:
o Clinical Trials Management System (CTMS); Business Intelligence (BI) and dashboards for CTMS; electronic Trial Master File (eTMF); Electronic Data Capture (EDC)/Thesaurus Management System (TMS) and underlying systems; Clinical Data Repository (CDR); Electronic Document Management System (EDMS); and others
• Assist with system upgrades and change requests and work in collaboration with Information Technology (IT) in the System Development Life Cycle (SDLC) from feasibility, gathering requirements to implementation, training and maintenance. Document the expected business outcomes that are supported by applications and any required data integrations, including expected service level agreements.
• Collaborate on planning and prioritization within Global Clinical Sciences and Operations (GCSO) and with IT.
• Act as delegate of the Process Data Owner (PDO) in the review and approval of system documentation.
• Provide operational data reporting and data discovery dashboards for review and analysis to support Clinical Teams on identifying data related issues, review study/program metrics, and provide an overview of cross-projects/trials analyses for various functions including Patient Safety, Patient Value Units and senior management as required.
• Provide advice on the selection of new solutions in areas of own in line with UCB’s strategy by evaluating new technologies and their potential use along with the business risks and benefits.
• Participate and may lead workstreams/taskforces to define the usage of clinical applications and business processes to achieve efficiencies and synergies in system support, eliminating redundancies and streamlining activities.
• Lead User Group/Stakeholders’ meetings and discussions ensuring alignment across departments.
• Provide training, mentoring, and guidance to team members as needed.
• Support audits and inspections as required and other responsibilities and projects that the Company may assign.

Skills & Requirements

Specific skills
• Strong computer proficiency, especially in use and management of databases, navigation of clinical solutions and generating reports.
• Ability to work cross-culturally and provide support and guidance to teams located worldwide.
• Advanced written and verbal communication skills. Strong communication skills with all levels of personnel globally, interpersonal skills and the tact and discretion required for negotiation within a global team setting to obtain cooperation and approval from other team members. Must be able to effectively organize ideas for logical presentation and acceptance.
• Experience in leading and participating in collaborative work teams at local and global levels.
• Experience in managing multiple tasks, projects and personnel concurrently.
• Self-motivating with the ability to work without supervision.
• Project management skills.
• Proficiency in English.
• Good organizational skills and problem-solving skills.
• Ability to engage and motivate application users.
• Experience in engaging key stakeholders and customers to influence and achieve optimal business objectives.
Problem solving
• Proactive problem solver, uses initiative, identifies problems and/or opportunities for improvement and proposes workable and acceptable solutions.
• High levels of initiative, drive and commitment with an ability to adopt an entrepreneurial and innovative style when required.
• Open minded, with ability to understand conflicting issues and priorities, and negotiate acceptable resolutions, across functions.
• Able to adapt to change and champion the change.
• Able to plan, perform, trouble-shoot and make decisions based on precedent, company policies, UCB procedures, international and national regulations and Good Clinical Practice (GCP).
• Ability to work accurately and efficiently and when necessary create new processes and procedures.
Experience
• 5+ years pharmaceutical/CRO setting.
• At least 3 years relevant experience in the clinical data / technology field in Drug Development or Life Sciences working with EDC, CTMS, TMF, MDR, CDR, COAR, BI reporting/dashboards, system integrations, and other systems.
• 3 years Good Practice (GxP) and system validation experience.
• Knowledge of clinical processes and technical framework.
• Previous experience creating new processes, SOPs and related documents.
• Knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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