Early Clinical Scientist (Job Share)
Location:
Boston , Massachusetts
Posted:
February 03, 2017
Reference:
CLI005627
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.

This position is a Job-Share - Part-time position (3 days/week)

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.

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. May provide mentoring to junior ECS.

Represents Early Stage Development on cross-functional teams to develop and/or improve internal job aids/SOPs. Identifies and communicates best practices within the organization. Promotes departmental adoption of new procedures.

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 update 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.

Overnight travel <5>
Please note: This is a job share position.

Requirements:

Education:
  • Bachelor of Science degree (or BSN) and a minimum of 7 years related* experience OR Master's degree and a minimum of 5 years related* experience
(*e.g., knowledge of clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing).

Required:
  • 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, project management, leadership, communication (written and verbal), issue identification and resolution skills
  • Knowledge of GCP, ICH guidelines and regulatory requirements
Preferred:
  • Global Phase I subject and patient trials, safety reporting, and regulatory WMA submission experience



Qualifications:
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.

This position is a Job-Share - Part-time position (3 days/week)

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.

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. May provide mentoring to junior ECS.

Represents Early Stage Development on cross-functional teams to develop and/or improve internal job aids/SOPs. Identifies and communicates best practices within the organization. Promotes departmental adoption of new procedures.

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 update 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.

Overnight travel <5>
Please note: This is a job share position.

Requirements:

Education:
  • Bachelor of Science degree (or BSN) and a minimum of 7 years related* experience OR Master's degree and a minimum of 5 years related* experience
(*e.g., knowledge of clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing).

Required:
  • 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, project management, leadership, communication (written and verbal), issue identification and resolution skills
  • Knowledge of GCP, ICH guidelines and regulatory requirements
Preferred:
  • Global Phase I subject and patient trials, safety reporting, and regulatory WMA submission experience


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.
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