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Early Clinical Scientist Job

Job Details

Early Clinical Scientist-CLI004948

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


Description

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 CRO performance to achieve project objectives and resolves project performance issues if they arise.

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Ensures appropriate clinical safety assessment and risk management of compounds

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Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues.

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Reviews and interprets clinical trial data.

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May conduct on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes.

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Applies knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.

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Contributes to teams developing and/or improving internal job aids/SOP.

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Identifies and communicates best practices within the organization.

Technical Writing and 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 update and safety reports, as well as clinical development plans, publications, and abstracts.

- Ensures documents are completed in accordance with applicable standards.

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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.

Qualifications

Education Requirement:

- Bachelor of Science degree (or BSN) and a minimum of 4 years related* experience

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Master’s degree and a minimum of ≥3 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:    

- 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 (CRO) 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.

Preferred Experience and Skills:

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Global Phase I subject and patient trials & safety reporting experience a plus

Overnight travel

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Clinical Research - Clin Ops

Job Title:Scientist, Clin. Operations

Primary Location: NA-US-MA-Boston

Employee Status: Regular

Number of Openings: 1

Hazardous Materials: None

Company Trade Name:Merck

Company

Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.

We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work

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