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Oncology Senior Study Manager. Job in Upper Gwynedd, Pennsylvania, United States in Merck & Co., Inc.. Nelest.com
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Oncology Senior Study Manager

col-narrow-left   

Job ID:

22158

Location:

Upper Gwynedd, PA 

Job function:

Research & Development
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Oncology Senior Study Manager

Job Description:

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.

The Senior Scientist, Clinical Operations will report to the Operational Program Lead for the Oncology Breast Indication and act as the key instrumental driver of the operational planning, feasibility and execution of clinical studies as the Lead of the Clinical Trial Team. The Study Manager will collaborate with the Clinical Director (physician), Clinical Scientist Protocol Lead and Medical Writer for the scientific and strategic aspects of the protocol and with regional representatives for country operational input.

Must be able to lead team in key study planning, development and execution elements (e.g., data management deliverables, protocol level plans/timelines, country/site selection, system updates, Investigator Meeting planning, communication plans, preparation of status update reports, study closeout activities). Fast-paced oncology environment requires this candidate to have excellent timeline management, risk identification/mitigation/issue resolution skills. Also, must facilitate and collaborate with key internal/external stakeholders (study team, subsidiary country teams, vendors, committees, etc) in support of clinical study objectives.
  • Operational point of contact for trial execution and all trial deliverables, i.e. managing the project schedule
  • Manages all Headquarters Operational Activities, including: Establishes, leads and manages Clinical Trial Team (CTT)
  • Supports clinical (drug) supplies planning
  • Manages deployment and interactions with external vendors
  • Initiates planning for Investigator meeting and protocol training.
  • Plans and assesses protocol ancillary supplies
  • Completes trial set-up and maintains Clinical Trial Management System data.
  • Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT
  • Initiates recruitment/retention planning & enrollment tracking
  • Responsible for tracking study related details (e.g., specimens, queries)
  • Oversees protocol training activities including Investigator Meetings and CRA training meetings
  • Ensures appropriate postings to Clinical portal for sites
  • Responsible for operational deliverables in preparation for site ready, country allocation and achievement of recruitment targets (with input from others)
  • Point of escalation for study related operational issues
  • Responsible for operational details at Operational Reviews
  • Responsible for creating and maintaining project schedule and collaborating with Program
  • Sets up and maintains Trial Master File
  • Ensures alignment of budget with protocol needs
  • Responsible for quality control and inspection readiness at all times


Travel: Yes, 5 % of the Time Description Oncology Senior Study Manager-CLI004616 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.
The Senior Scientist, Clinical Operations will report to the Operational Program Lead for the Oncology Breast Indication and act as the key instrumental driver of the operational planning, feasibility and execution of clinical studies as the Lead of the Clinical Trial Team. The Study Manager will collaborate with the Clinical Director (physician), Clinical Scientist Protocol Lead and Medical Writer for the scientific and strategic aspects of the protocol and with regional representatives for country operational input.
Must be able to lead team in key study planning, development and execution elements (e.g., data management deliverables, protocol level plans/timelines, country/site selection, system updates, Investigator Meeting planning, communication plans, preparation of status update reports, study closeout activities). Fast-paced oncology environment requires this candidate to have excellent timeline management, risk identification/mitigation/issue resolution skills. Also, must facilitate and collaborate with key internal/external stakeholders (study team, subsidiary country teams, vendors, committees, etc) in support of clinical study objectives.
  • Operational point of contact for trial execution and all trial deliverables, i.e. managing the project schedule
  • Manages all Headquarters Operational Activities, including: Establishes, leads and manages Clinical Trial Team (CTT)
  • Supports clinical (drug) supplies planning
  • Manages deployment and interactions with external vendors
  • Initiates planning for Investigator meeting and protocol training.
  • Plans and assesses protocol ancillary supplies
  • Completes trial set-up and maintains Clinical Trial Management System data.
  • Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT
  • Initiates recruitment/retention planning & enrollment tracking
  • Responsible for tracking study related details (e.g., specimens, queries)
  • Oversees protocol training activities including Investigator Meetings and CRA training meetings
  • Ensures appropriate postings to Clinical portal for sites
  • Responsible for operational deliverables in preparation for site ready, country allocation and achievement of recruitment targets (with input from others)
  • Point of escalation for study related operational issues
  • Responsible for operational details at Operational Reviews
  • Responsible for creating and maintaining project schedule and collaborating with Program
  • Sets up and maintains Trial Master File
  • Ensures alignment of budget with protocol needs
  • Responsible for quality control and inspection readiness at all times

Job Requirements:

Qualifications Education:
  • Bachelor's degree with at least 7 years relevant career experience OR Master's degree with at least 5 years relevant career experience OR a PhD with at least 2 years relevant career experience
  • Degree in the Life Sciences or significant experience in clinical development
Required:
  • Pharmaceutical and/or clinical drug development experience
  • Excellent oral (including presentation) and written communication, computer/ database management and project management skills
Preferred:
  • Experience leading cross-functional teams


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.

Zip Code:

19446

Company Info
Merck & Co., Inc.

Kenilworth, NJ, United States

Phone:
Web Site: merck.com

Company Profile

Company Info


Merck & Co., Inc.
Kenilworth, NJ, United States
Phone:
Web Site: merck.com

Oncology Senior Study Manager

col-narrow-left   

Job ID:

22158

Location:

Upper Gwynedd, PA 

Job function:

Research & Development
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Oncology Senior Study Manager

Job Description:

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.

The Senior Scientist, Clinical Operations will report to the Operational Program Lead for the Oncology Breast Indication and act as the key instrumental driver of the operational planning, feasibility and execution of clinical studies as the Lead of the Clinical Trial Team. The Study Manager will collaborate with the Clinical Director (physician), Clinical Scientist Protocol Lead and Medical Writer for the scientific and strategic aspects of the protocol and with regional representatives for country operational input.

Must be able to lead team in key study planning, development and execution elements (e.g., data management deliverables, protocol level plans/timelines, country/site selection, system updates, Investigator Meeting planning, communication plans, preparation of status update reports, study closeout activities). Fast-paced oncology environment requires this candidate to have excellent timeline management, risk identification/mitigation/issue resolution skills. Also, must facilitate and collaborate with key internal/external stakeholders (study team, subsidiary country teams, vendors, committees, etc) in support of clinical study objectives.
  • Operational point of contact for trial execution and all trial deliverables, i.e. managing the project schedule
  • Manages all Headquarters Operational Activities, including: Establishes, leads and manages Clinical Trial Team (CTT)
  • Supports clinical (drug) supplies planning
  • Manages deployment and interactions with external vendors
  • Initiates planning for Investigator meeting and protocol training.
  • Plans and assesses protocol ancillary supplies
  • Completes trial set-up and maintains Clinical Trial Management System data.
  • Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT
  • Initiates recruitment/retention planning & enrollment tracking
  • Responsible for tracking study related details (e.g., specimens, queries)
  • Oversees protocol training activities including Investigator Meetings and CRA training meetings
  • Ensures appropriate postings to Clinical portal for sites
  • Responsible for operational deliverables in preparation for site ready, country allocation and achievement of recruitment targets (with input from others)
  • Point of escalation for study related operational issues
  • Responsible for operational details at Operational Reviews
  • Responsible for creating and maintaining project schedule and collaborating with Program
  • Sets up and maintains Trial Master File
  • Ensures alignment of budget with protocol needs
  • Responsible for quality control and inspection readiness at all times


Travel: Yes, 5 % of the Time Description Oncology Senior Study Manager-CLI004616 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.
The Senior Scientist, Clinical Operations will report to the Operational Program Lead for the Oncology Breast Indication and act as the key instrumental driver of the operational planning, feasibility and execution of clinical studies as the Lead of the Clinical Trial Team. The Study Manager will collaborate with the Clinical Director (physician), Clinical Scientist Protocol Lead and Medical Writer for the scientific and strategic aspects of the protocol and with regional representatives for country operational input.
Must be able to lead team in key study planning, development and execution elements (e.g., data management deliverables, protocol level plans/timelines, country/site selection, system updates, Investigator Meeting planning, communication plans, preparation of status update reports, study closeout activities). Fast-paced oncology environment requires this candidate to have excellent timeline management, risk identification/mitigation/issue resolution skills. Also, must facilitate and collaborate with key internal/external stakeholders (study team, subsidiary country teams, vendors, committees, etc) in support of clinical study objectives.
  • Operational point of contact for trial execution and all trial deliverables, i.e. managing the project schedule
  • Manages all Headquarters Operational Activities, including: Establishes, leads and manages Clinical Trial Team (CTT)
  • Supports clinical (drug) supplies planning
  • Manages deployment and interactions with external vendors
  • Initiates planning for Investigator meeting and protocol training.
  • Plans and assesses protocol ancillary supplies
  • Completes trial set-up and maintains Clinical Trial Management System data.
  • Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT
  • Initiates recruitment/retention planning & enrollment tracking
  • Responsible for tracking study related details (e.g., specimens, queries)
  • Oversees protocol training activities including Investigator Meetings and CRA training meetings
  • Ensures appropriate postings to Clinical portal for sites
  • Responsible for operational deliverables in preparation for site ready, country allocation and achievement of recruitment targets (with input from others)
  • Point of escalation for study related operational issues
  • Responsible for operational details at Operational Reviews
  • Responsible for creating and maintaining project schedule and collaborating with Program
  • Sets up and maintains Trial Master File
  • Ensures alignment of budget with protocol needs
  • Responsible for quality control and inspection readiness at all times

Job Requirements:

Qualifications Education:
  • Bachelor's degree with at least 7 years relevant career experience OR Master's degree with at least 5 years relevant career experience OR a PhD with at least 2 years relevant career experience
  • Degree in the Life Sciences or significant experience in clinical development
Required:
  • Pharmaceutical and/or clinical drug development experience
  • Excellent oral (including presentation) and written communication, computer/ database management and project management skills
Preferred:
  • Experience leading cross-functional teams


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.

Zip Code:

19446
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