Senior Study Manager, Epidemiology Operations
Job Description New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.Support the Lead Epi Scientists by providing overall operational support for study conduct. Responsible for the coordination and execution of observational or non-interventional research studies (including Post Authorization studies), in compliance with Good Pharmacoepidemiology Practice (GPP) and Standard Operating Procedures (SOPs). Manages several complex activities and study types. Primary responsibilities include:
Operational planning and project management of epidemiology research studies.
Execution, and close out of primary data collection, chart review, database, and molecular epidemiology studies in addition to other activities.
Manage vendors including qualification efforts, confidentiality agreements, specifications, and contract reviews.
Assist with review and finalization of all vendor documents such as the safety management, data management, communication, project management and validation plans.
Participate in protocol and interim/final report preparation, shepherd document through the internal review process for approval, and upload to department repository.
Coordination of collection, international shipment, processing by internal/external labs and data transfer for biospecimen- based studies.
Participate in quality control assessments and ensure integrity of study data for reports and publications.
Understand, coordinate, and document adherence to internal, external, and regulatory compliance requirements.
Collaborate extensively and troubleshoot issues by providing potential resolutions when necessary to ensure timely management and execution of studies.
Manage poster and publication development including:
formatting, medical writing, figure/data content development, co-author review, internal review process, and journal submissions.
Conduct literature reviews.
Active participation in internal process improvement initiatives and mentoring of junior study managers. Minimum required education:
Bachelor's degree required / Master's degree (preferred) in public health (or closely related discipline, such as biostatistics, epidemiology, health administration or biological sciences). Required experience and skills:
Five (5)
years of work experience within clinical/observational research or equivalent experience; or PhD with 3
years relevant career experience.
Excellent communication and interpersonal skills and the ability to collaborate with and influence a wide variety of stakeholders.
Knowledge of epidemiology and/or outcomes research.
Strong project management and prioritization skills.
Highly motivated, able to work independently and collaboratively.We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.MRLGCTO Who we are We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join usand start making your impact today. NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.Current Employees apply HERE (https:
//wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)Current Contingent Workers apply HERE (https:
//wd5.myworkday.com/msd/d/task/1422$4020.htmld) US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https:
//survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster (https:
//www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)EEOC GINA Supplement?OFCCP EEO Supplement (https:
//www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)Pay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Search Firm Representatives Please Read Carefully Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status:
Regular Relocation:
No relocation VISA Sponsorship:
No Travel Requirements:
10% Flexible Work Arrangements:
Shift:
Valid Driving License:
Yes Hazardous Material(s):
Number of Openings:
4 Requisition ID:
R179777
Salary Range:
$80K
Minimum Qualification
Education AdministrationEstimated Salary: $20 to $28 per hour based on qualifications.
Operational planning and project management of epidemiology research studies.
Execution, and close out of primary data collection, chart review, database, and molecular epidemiology studies in addition to other activities.
Manage vendors including qualification efforts, confidentiality agreements, specifications, and contract reviews.
Assist with review and finalization of all vendor documents such as the safety management, data management, communication, project management and validation plans.
Participate in protocol and interim/final report preparation, shepherd document through the internal review process for approval, and upload to department repository.
Coordination of collection, international shipment, processing by internal/external labs and data transfer for biospecimen- based studies.
Participate in quality control assessments and ensure integrity of study data for reports and publications.
Understand, coordinate, and document adherence to internal, external, and regulatory compliance requirements.
Collaborate extensively and troubleshoot issues by providing potential resolutions when necessary to ensure timely management and execution of studies.
Manage poster and publication development including:
formatting, medical writing, figure/data content development, co-author review, internal review process, and journal submissions.
Conduct literature reviews.
Active participation in internal process improvement initiatives and mentoring of junior study managers. Minimum required education:
Bachelor's degree required / Master's degree (preferred) in public health (or closely related discipline, such as biostatistics, epidemiology, health administration or biological sciences). Required experience and skills:
Five (5)
years of work experience within clinical/observational research or equivalent experience; or PhD with 3
years relevant career experience.
Excellent communication and interpersonal skills and the ability to collaborate with and influence a wide variety of stakeholders.
Knowledge of epidemiology and/or outcomes research.
Strong project management and prioritization skills.
Highly motivated, able to work independently and collaboratively.We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.MRLGCTO Who we are We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join usand start making your impact today. NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.Current Employees apply HERE (https:
//wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)Current Contingent Workers apply HERE (https:
//wd5.myworkday.com/msd/d/task/1422$4020.htmld) US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https:
//survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster (https:
//www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)EEOC GINA Supplement?OFCCP EEO Supplement (https:
//www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)Pay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Search Firm Representatives Please Read Carefully Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status:
Regular Relocation:
No relocation VISA Sponsorship:
No Travel Requirements:
10% Flexible Work Arrangements:
Shift:
Valid Driving License:
Yes Hazardous Material(s):
Number of Openings:
4 Requisition ID:
R179777
Salary Range:
$80K
Minimum Qualification
Education AdministrationEstimated Salary: $20 to $28 per hour based on qualifications.
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