Early Clinical Scientist (Job Share) 3 days per week
- Employer
- Merck
- Location
- Boston MA
- Closing date
- Mar 13, 2017
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Job Details
Early Clinical Scientist (Job Share) 3 days per week-CLI005627
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.
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
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
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.
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.
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:Sr. Scientist, Clin. Operations
Primary Location: NA-US-MA-Boston
Other Locations: NA-US-PA-Upper Gwynedd, NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Company Trade Name:Merck
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.
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
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
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.
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.
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:Sr. Scientist, Clin. Operations
Primary Location: NA-US-MA-Boston
Other Locations: NA-US-PA-Upper Gwynedd, NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
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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