Job Description:
Merck is a global health care leader with a diversified portfolio of prescription medicines, and vaccines, as well as 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 people 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.
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 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.
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.
Qualifications
Education:
* Bachelor of Science degree (or BSN) and 7-11 years related* experience, OR
* Master’s degree and 5-8 years related* experience (*e.g., clinical trial management, clinical site training/monitoring; medical and regulatory writing).
Required Experience and Skills:
* Understanding of clinical research development process from program planning to regulatory submission.
* Ability 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 Experience and Skills:
* Global Phase I subject and patient trials, safety reporting, and regulatory WMA submission experience a plus.
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. Merck’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 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. ZZ5ML
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Clinical Research (Non-M.D.)
Job Title:Senior Scientist, Clinical Research
Primary Location: NA-US-PA-Upper Gwynedd
Other Locations: NA-US-MA-Boston, NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Additional Info:
[Click Here to Access the Original Job Post]
Merck is a global health care leader with a diversified portfolio of prescription medicines, and vaccines, as well as 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 people 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.
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 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.
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.
Qualifications
Education:
* Bachelor of Science degree (or BSN) and 7-11 years related* experience, OR
* Master’s degree and 5-8 years related* experience (*e.g., clinical trial management, clinical site training/monitoring; medical and regulatory writing).
Required Experience and Skills:
* Understanding of clinical research development process from program planning to regulatory submission.
* Ability 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 Experience and Skills:
* Global Phase I subject and patient trials, safety reporting, and regulatory WMA submission experience a plus.
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. Merck’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 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. ZZ5ML
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Clinical Research (Non-M.D.)
Job Title:Senior Scientist, Clinical Research
Primary Location: NA-US-PA-Upper Gwynedd
Other Locations: NA-US-MA-Boston, NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Skills :
Areas :
Additional Info:
[Click Here to Access the Original Job Post]