Trial Operation Lead/Clinical Research Scientist
HAYS

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Pharmaceutical Company is seeking a Trial Operation Lead/Clinical Research Scientist in Rockville , MD.

Role Description

The Clinical Research Scientist will conduct collaborative research projects that are aligned with the strategic mission of the Research department. Lead the planning, execution and reporting of clinical trials on time, within budget and in compliance with company processes and regulatory requirements

• Serve as support to Clinical Trial Leader for clinical trials and be responsible for assisting with the preparation of the protocol-related documents in IRB submission, eCRF development, data review, report and publication.
• Responsibilities for the execution of clinical trials (trial timelines, budget, resources, safety, eligibility, enrollment and data consistency). Contribute to the preparation of clinical program documents (investigator brochure, IND annual report, HA briefing books and submissions).
• Part of the clinical trial team working with site staff throughout the trial execution. Coach and work collaboratively with team members. Actively contribute to multidisciplinary teams to support continuous improvement
• Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality and data integrity
• Oversight of all activities listed and ensures all duties/documents/protocols to meet quality and integrity expectations, and delivers them in accordance with the sponsor expectations, trial protocol, GCP guidelines and applicable SOPs (local/US/international)
• Verifies that the rights and well-being of human subjects are protected, and that the reported trial data are accurate, complete and verifiable from source documents
• Coordinates and oversees the development of study protocols and amendments, and cooperates in the development of other essential materials for clinical studies, providing expertise and input throughout
• Obtain, review, and process necessary regulatory and administrative reports. Review essential regulatory documents to ensure completeness, accuracy, and regulatory compliance.
• Interact with other functional areas and key stakeholders, including Clinical Development and Clinical Operations; Regulatory Affairs, Data Management, Finance, Regulatory, Quality Assurance, Safety, and Human Resources as needed, to support clinical trial activities.
• Obtain and relay key study issues, status updates and other study information to the clinical trial team and management
• Review data to identify protocol deviations and risks to subject safety/data integrity and evaluate execution of study protocol at the site level. Uses judgment and experience to assess the overall performance of site and site staff to provide recommendations regarding site-specific actions; immediately communicate/escalate severe issues to the study team.

Skills & Requirements

• MS in Life Sciences (or BS plus equivalent experience) PhD or PharmD from an accredited college or university required. BSN/MS in Nursing preferred.
• A Minimum of 3-5 years' experience in drug development in Biotech/Life Sciences or Pharmaceutical company. Five years' Oncology and early phase clinical experience strongly preferred.
• Knowledge of and ability to manage Oncology clinical trial design, technical expertise in data management skills and pharmacokinetics. Write reports and publications.
• Demonstrated ability to analyze, interpret and present complex clinical and scientific data
• Ability to recognize the safety and efficacy of data trends.
• Familiar with all aspects of the clinical development process.
• Knowledge of GCP and regulatory requirements.
• Experience in both early and late phase development
• Interpersonal versatility leads through influence with the ability to manage and simultaneously serve as an individual contributor and a leader, and think strategically and tactically, and motivated to work in a fast-paced, high accountability environment.
• Excellent interpersonal communication and presentations skills with a proficiency in presenting clinical and non-clinical data to internal and external audiences
• Thorough understanding of US healthcare environment, clinical research process, FDA and other federal regulations and ethical guideline

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the Information Technology 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 an Equal Opportunity Employer.

Drug testing may be required; please contact a recruiter for more information.
#1118658