Sr. Scientist, Clinical Research

Merck & Co. • West Point, PA

279d • $114,700 - $180,500 • Onsite

About The Position

The Early Clinical Scientist/ECS 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 and 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 thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development. Represents Early Stage Development on cross-functional teams to develop and/or improve internal job aids/SOP/clinical development procedures. Identifies and communicates best practices within the organization. Promotes departmental adaptation of new procedures.

Requirements

• Degree in Life Sciences or related field.
• Bachelor's degree and ≥6 years related experience OR Master's degree and ≥4 years related experience OR PhD and ≥2 years related experience.
• Understanding of clinical research development process from program planning to regulatory submission.
• Ability to manage complex operations and projects under accelerated timelines.
• Scientific, medical and/or safety writing and reporting experience.
• Ability to partner effectively with internal and external teams.

Nice To Haves

• Global Phase I subject and patient trials experience.
• Safety reporting and regulatory WMA submission experience.

Responsibilities

• Coordinate the design, planning, and execution of early phase clinical trials.
• Oversee trials within and/or across program(s)/therapeutic areas.
• Manage internal/external team performance to achieve project objectives.
• Conduct real-time oversight of ongoing trials to identify and mitigate issues.
• Review and interpret clinical trial data.
• Co-author clinical sections of protocols, clinical investigator brochures, and clinical study reports.
• Develop study operational documents with input from team members.
• Manage trial and program projects including team activities and risk assessment.

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