Scientist, Clinical Research (Hybrid)

Merck & Co. • West Point, PA

235d • $85,600 - $134,800 • Onsite

About The Position

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Translational Medicine is responsible for early clinical development of novel therapeutics, working in close collaboration with Discovery Sciences and late-stage Clinical Research across all therapeutic areas. Our team is focused on innovation and dedicated to translating breakthrough science into innovative medicines that extend and improve the lives of patients worldwide. Through clinical trials, we ensure the safety and efficacy of our pipeline and existing products to produce safe, effective, innovative medicine.

Requirements

• Degree in Life Sciences - Bachelor's degree and ≥4 years related experience, OR Master's degree or higher and 1+ years related experience.
• Understanding of clinical research development process from program planning to regulatory submission.
• Able to quickly develop a working scientific knowledge of different therapeutic areas.
• Ability to manage complex operations and projects under accelerated timelines.
• Scientific, medical and/or safety writing and reporting (at least one is required).
• Ability to partner effectively with internal and external teams to achieve results.
• Strong team collaboration, leadership, communication (written and verbal), issue identification and resolution skills.
• Knowledge of GCP, ICH guidelines and regulatory requirements.

Nice To Haves

• Global Phase I subject and patient trials & safety reporting experience.

Responsibilities

• Coordinates the design, planning and execution of early phase clinical trials with the Clinical Director and internal/external team members.
• Oversees trials within and/or across program(s)/therapeutic areas.
• Ensures excellence in execution/compliance to support study objectives and data validity.
• Manages internal/external team performance to achieve project objectives and resolves project performance issues if they arise.
• Ensures appropriate clinical safety assessment and risk management of compounds.
• Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues.
• Reviews and interprets clinical trial data.
• May conduct on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes.
• Applies knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
• Contributes to teams developing and/or improving internal job aids/SOPs.
• Identifies and communicates best practices within the organization.
• Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, and regulatory agency updates and safety reports.
• Develops study operational documents with input from team members (e.g. site monitoring plan, study operations manual, informed consent, etc.).
• Manages trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.), provides risk assessment and contingency planning, under accelerated timelines.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree