What are the responsibilities and job description for the Scientist, Clinical Research position at Merck?
Job Description
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.
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. 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.
Technical Writing & Communications
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, as well as clinical development plans, publications, and abstracts. Ensures documents are completed in accordance with applicable standards. Develops study operational documents with input from team members (e.g. site monitoring plan, study operations manual, informed consent, etc.).
Project Management
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. Familiar with early drug development processes, building knowledge and skills to effectively manage additional processes / procedures.
Education Minimum Requirement :
- Degree in Life Sciences
- Bachelor’s degree and ≥4 years related
- experience, OR Master’s degree or higher and 1 years related
- experience
- e.g., knowledge of clinical trial management and trial execution; clinical site training / monitoring; medical and regulatory writing; OR equivalent experience with developing preclinical model experiments for drug candidates (protocol authoring, experiment execution / oversight, authoring experiment reports).
Required Experience and Skills :
Preferred Experience and Skills :
US and Puerto Rico Residents Only :
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.
Expected US salary range :
85,600.00 - $134,800.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
Employee Status : Regular
Relocation : No relocation
VISA Sponsorship :
Travel Requirements :
Flexible Work Arrangements :
Hybrid
Shift : 1st - Day
Valid Driving License :
Hazardous Material(s) :
N / A
Job Posting End Date :
02 / 14 / 2025
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Salary : $85,600 - $134,800
