Risk Evaluation and Central Analytics Manager (RECAM)
Job Description _CORE Accountabilities and
Responsibilities:
_ Overarching
Responsibilities:
It is business critical that our company receives consistent, accurate, high-quality data from clinical trials conducted worldwide.
REAIM organization brings our company into a state of the art model and new ways of working to manage Risk and central analytics and ensure exquisite oversight of our clinical trials.
Under the oversight of the Risk Evaluation and Adaptive Integrated Central Analytics Lead (RAL), the RECAM is responsible for the conduct of sound risk evaluation and central analytic principles incorporation into the assigned trials.
Among key responsibilities are:
RISK EVALUATION AND CENTRAL ANALYTICSIs responsible of ensuring that sound risk evaluation and central analytic principles are incorporated into the assigned trials in support of regulatory filings.
This includes all operational risk evaluation and central analytics management:
o AIM system/software validation and maintenance,o Implementation of central analytics & monitoring activities, including Quality Tolerance Limit (QTL) analysis, Key Risk Indicator (KRI) study analysis and Central Statistical Analyticso Preparation of configuration plans for Risk Analysis components from both business and technical perspective, ensuring Risk Analysis modules reflects protocol changeso Assessment of potential Study changes affecting Risk Analysiso AIM adoption and alignment across all study plans (i.
e.
Site Monitoring, Data Management, Quality Management etc.
)Ensures consistent and standard processes in REAIM are used across our company's teams in the assigned trials, and that processes meet worldwide regulatory guidelines.
CENTRAL MONITORING PLANSResponsible for the definition, development and maintenance of Central Monitoring Plans (CMP) and the applicable design specifications for Risk Analysis components from both business and technical perspective and for the cooperation with the Suppliers Support Team during configuration of those, leading the facilitation of discussions with the Clinical Trial Team as applicableExecutes central analytics & monitoring activities as outlined in CMP, including QTL and KRI analysis and Central Statistical Analytics aligned with critical data, process and risk assessments, to support identification of important study issues and risks which require monitoring, management and adaptation of study plans during study conduct (taking part in risk reassessment process)Collectively and periodically supports a portfolio-level review of central monitoring plans and risk mitigation approaches within a specific therapy area, partnering with the Clinical Quality Operations Managers (CQOM) in order to identify any emerging signals or trends and provide relevant feedback to the RAL and/or Head of REAIM as appropriate.
COLLABORATIONProactively collaborates with stakeholders in Global Clinical Development (GCD) and GCTO like Medical Monitors, Clinical Scientists, CQOMs, Global Data Management Standards (GDMS), Biostatistics and Research Decision Sciences (BARDS) Statisticians and rest of members of the Clinical Trial Teams (including Country roles).
REAIM STRATEGY Contributes to the standardization of REAIM procedures, tools and templates to ensure consistency and seamless progression through the study lifecycle.
Works with peers to analyse data within and across protocols and identify signals and trends that will support process improvement strategies.
Minimum education required:
Bachelors/ Masters Degree or equivalent in relevant health care Minimum B.
A.
or B.
S.
degree, preferably in Data Science, Statistics, Pharmacy, Nursing, Biological Sciences, or health care related discipline.
Further formal education in quality management or business management is desirable.
Required experience and skills:
Relevant 6-8 years experience in clinical research and data analytics, experience with developing and managing central monitoring plans recommended.
Profound knowledge and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools is required.
Expert knowledge of International Conference on Harmonization Good Clinical Practice (ICHGCP) E6 risk-based quality management (RBQM) methodology and worldwide Regulatory Health Authority requirements and Good Documentation Practices.
Experience with risk management tools and processes within the clinical quality framework.
Superior oral and written communication skills in an international environment.
Excellent project management and organizational skills.
Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
Ability to lead cross-functional teams of business professionals within and outside our Research & Development Division.
Ability to identify, analyze, interpret and solve complex problems, conflicts, and opportunities early and lead, analyze mitigation plans and drive conflict resolution is critical.
Ability to think strategically and objectively and with creativity and innovation.
Ability to proficiently interact with all levels of specialists & management and exert influence to achieve results.
Ability to think cross-functionally and working across boundaries internationally.
Profound understanding of data and metrics, technical skills
Possess Data Literacy skill sets:
i.
e.
have the ability to read, understand, create, and communicate data as information by prioritizing cultural change within our company's Business and fostering a data-driven mindset and orientation, i.
e.
use of KRIs and QTLs in adaptive risk assessment, evaluation and decision making.
MRLGCTO#eligibleforERP 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.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.
Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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 Know Your Rights ( https:
//www.
eeoc.
gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.
pdf) />EEOC GINA Supplement? Pay Transparency Nondiscrimination (https:
//www.
dol.
gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.
pdf) We 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.
U.
S.
Hybrid Work Model Effective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Learn more about your rights, including under California, Colorado and other US State Acts ( https:
//www.
msdprivacy.
com/us/en/CCPA-notice/) /> Search Firm Representatives Please Read Carefully Merck & Co.
, Inc.
, Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:
Remote Work, Telecommuting, Work Week Shift:
1st - Day Valid Driving License:
Hazardous Material(s):
Requisition ID:
R246393 Recommended Skills Analytical Business Management Business Process Improvement Clinical Development Clinical Research Clinical Trials Estimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
_ Overarching
Responsibilities:
It is business critical that our company receives consistent, accurate, high-quality data from clinical trials conducted worldwide.
REAIM organization brings our company into a state of the art model and new ways of working to manage Risk and central analytics and ensure exquisite oversight of our clinical trials.
Under the oversight of the Risk Evaluation and Adaptive Integrated Central Analytics Lead (RAL), the RECAM is responsible for the conduct of sound risk evaluation and central analytic principles incorporation into the assigned trials.
Among key responsibilities are:
RISK EVALUATION AND CENTRAL ANALYTICSIs responsible of ensuring that sound risk evaluation and central analytic principles are incorporated into the assigned trials in support of regulatory filings.
This includes all operational risk evaluation and central analytics management:
o AIM system/software validation and maintenance,o Implementation of central analytics & monitoring activities, including Quality Tolerance Limit (QTL) analysis, Key Risk Indicator (KRI) study analysis and Central Statistical Analyticso Preparation of configuration plans for Risk Analysis components from both business and technical perspective, ensuring Risk Analysis modules reflects protocol changeso Assessment of potential Study changes affecting Risk Analysiso AIM adoption and alignment across all study plans (i.
e.
Site Monitoring, Data Management, Quality Management etc.
)Ensures consistent and standard processes in REAIM are used across our company's teams in the assigned trials, and that processes meet worldwide regulatory guidelines.
CENTRAL MONITORING PLANSResponsible for the definition, development and maintenance of Central Monitoring Plans (CMP) and the applicable design specifications for Risk Analysis components from both business and technical perspective and for the cooperation with the Suppliers Support Team during configuration of those, leading the facilitation of discussions with the Clinical Trial Team as applicableExecutes central analytics & monitoring activities as outlined in CMP, including QTL and KRI analysis and Central Statistical Analytics aligned with critical data, process and risk assessments, to support identification of important study issues and risks which require monitoring, management and adaptation of study plans during study conduct (taking part in risk reassessment process)Collectively and periodically supports a portfolio-level review of central monitoring plans and risk mitigation approaches within a specific therapy area, partnering with the Clinical Quality Operations Managers (CQOM) in order to identify any emerging signals or trends and provide relevant feedback to the RAL and/or Head of REAIM as appropriate.
COLLABORATIONProactively collaborates with stakeholders in Global Clinical Development (GCD) and GCTO like Medical Monitors, Clinical Scientists, CQOMs, Global Data Management Standards (GDMS), Biostatistics and Research Decision Sciences (BARDS) Statisticians and rest of members of the Clinical Trial Teams (including Country roles).
REAIM STRATEGY Contributes to the standardization of REAIM procedures, tools and templates to ensure consistency and seamless progression through the study lifecycle.
Works with peers to analyse data within and across protocols and identify signals and trends that will support process improvement strategies.
Minimum education required:
Bachelors/ Masters Degree or equivalent in relevant health care Minimum B.
A.
or B.
S.
degree, preferably in Data Science, Statistics, Pharmacy, Nursing, Biological Sciences, or health care related discipline.
Further formal education in quality management or business management is desirable.
Required experience and skills:
Relevant 6-8 years experience in clinical research and data analytics, experience with developing and managing central monitoring plans recommended.
Profound knowledge and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools is required.
Expert knowledge of International Conference on Harmonization Good Clinical Practice (ICHGCP) E6 risk-based quality management (RBQM) methodology and worldwide Regulatory Health Authority requirements and Good Documentation Practices.
Experience with risk management tools and processes within the clinical quality framework.
Superior oral and written communication skills in an international environment.
Excellent project management and organizational skills.
Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
Ability to lead cross-functional teams of business professionals within and outside our Research & Development Division.
Ability to identify, analyze, interpret and solve complex problems, conflicts, and opportunities early and lead, analyze mitigation plans and drive conflict resolution is critical.
Ability to think strategically and objectively and with creativity and innovation.
Ability to proficiently interact with all levels of specialists & management and exert influence to achieve results.
Ability to think cross-functionally and working across boundaries internationally.
Profound understanding of data and metrics, technical skills
Possess Data Literacy skill sets:
i.
e.
have the ability to read, understand, create, and communicate data as information by prioritizing cultural change within our company's Business and fostering a data-driven mindset and orientation, i.
e.
use of KRIs and QTLs in adaptive risk assessment, evaluation and decision making.
MRLGCTO#eligibleforERP 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.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.
Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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 Know Your Rights ( https:
//www.
eeoc.
gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.
pdf) />EEOC GINA Supplement? Pay Transparency Nondiscrimination (https:
//www.
dol.
gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.
pdf) We 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.
U.
S.
Hybrid Work Model Effective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Learn more about your rights, including under California, Colorado and other US State Acts ( https:
//www.
msdprivacy.
com/us/en/CCPA-notice/) /> Search Firm Representatives Please Read Carefully Merck & Co.
, Inc.
, Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:
Remote Work, Telecommuting, Work Week Shift:
1st - Day Valid Driving License:
Hazardous Material(s):
Requisition ID:
R246393 Recommended Skills Analytical Business Management Business Process Improvement Clinical Development Clinical Research Clinical Trials Estimated Salary: $20 to $28 per hour based on qualifications.
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