Clinical Trial Data Management Intern
Job Description Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement.
Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.
The Future Talent Program features internships that lasts up to 12 weeks and will include one or more projects.
These opportunities in our Research Division can provide you with great development and a chance to see if we are the right company for your long-term goals.
Our clinical team is recruiting for summer interns within the trial manager area of our company.
The Trial Data Manager:
Creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine program.
Develops and manages project plans which span from protocol development through database lock.
Collaborates with appropriate functional areas to align resources and ensure all aspects of the project plan are executed on time and with appropriate quality.
Agrees/arbitrates deliverable-based commitments based on detailed knowledge of trial complexity and requirements.
Manages change, customer and stakeholder expectations, facilitates cross-functional decision making, and performs risk management.
Represents Global Data Management on cross-functional trial teams and in other trial-level development forums.
Under the guidance of more senior staff, may serve as the data management lead or perform a support role for filing programs.
Participates in the development of, and ensures adherence to, our Company clinical data management procedures.
Interacts with staff across multiple our Company sites.
Primary Activities include but are not limited to:
Develops detailed project plans for the collection, review, and cleaning of all clinical data for assigned trials within a specific drug / vaccine program.
Data includes, but is not limited to, case report form (CRF) data, lab data, biomarker data, and patient reported outcomes.
Serves as project manager of all clinical data management activities for trials as assigned.
Under the guidance of more senior staff when appropriate, uses excellent interpersonal, negotiating, and project management skills to perform and manage the following tasks:
Project planning, initiation, execution, change control, and closing.
Project team development, project team leadership, meeting management, and resource coordination.
Risk management planning (ie, risk identification, analysis, response planning, monitoring, and control), including escalation as necessary.
Management of customer / stakeholder expectations; facilitation of cross-functional decisions.
Defines trial-level requirements for quality data collection and validation at the trial level.
Reads and interprets the clinical protocol from a clinical data management perspective.
Provides clinical data management input into trial design, as appropriate, ensuring operational feasibility.
Engages with key stakeholders and subject matter experts to assess complexity, define trial-level data management requirements and inputs (including timing), and confirm all data management deliverables and services required for a trial.
Ensures appropriate use of standards and project-level consistency of database design, data collection, and validation.
Facilitates assessment and processing of standards and change requests.
Approves trial-level data validation plan (including project and protocol specific data validation elements).
Manages trial-level data quality and completion of database lock and post-database lock activities:
Monitors overall status and quality of data being collected during the in-life portion of a trial.
Engages with key stakeholders and subject matter experts to refine data management tools and validation plans, as appropriate.
Ensures activities required to achieve database lock (or data extraction) are completed by appropriate, responsible functional area.
Ensures timely archival of trial data and documentation.
Ensures timely decommissioning of clinical data management technologies.
Accountable for ensuring the successful execution of delivery of data management services provided by external partners engaged for outsourced trials, as assigned.
Supports site and sponsor audits, as appropriate.
Identifies and supports improvements to data collection and data management processes and tools.
Required Education and Skills:
Candidates must be working towards a BA or BS degree, preferably in life sciences, computer science, or related discipline.
Candidates must be available to work full-time for up to (12) weeks beginning in May or June of 2022.
Candidates must have interest in learning Clinical Data Management.
Preferred Experience and Skills:
Candidates should have basic understanding of the clinical research process.
Candidates should have strong organization and management skills.
Candidates must be able to communicate effectively - orally and in written form - with technical and business areas.
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation.
Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
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 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 us-and start making your impact today.
FTP2022Current 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 another's 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:
Intern/Co-op (Fixed Term) Relocation:
No relocation VISA Sponsorship:
No Travel Requirements:
No Travel Required Flexible Work Arrangements:
Flex Time, Remote Work, Telecommuting Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
2 Requisition ID:
R137714.
Estimated Salary: $20 to $28 per hour based on qualifications.
Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.
The Future Talent Program features internships that lasts up to 12 weeks and will include one or more projects.
These opportunities in our Research Division can provide you with great development and a chance to see if we are the right company for your long-term goals.
Our clinical team is recruiting for summer interns within the trial manager area of our company.
The Trial Data Manager:
Creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine program.
Develops and manages project plans which span from protocol development through database lock.
Collaborates with appropriate functional areas to align resources and ensure all aspects of the project plan are executed on time and with appropriate quality.
Agrees/arbitrates deliverable-based commitments based on detailed knowledge of trial complexity and requirements.
Manages change, customer and stakeholder expectations, facilitates cross-functional decision making, and performs risk management.
Represents Global Data Management on cross-functional trial teams and in other trial-level development forums.
Under the guidance of more senior staff, may serve as the data management lead or perform a support role for filing programs.
Participates in the development of, and ensures adherence to, our Company clinical data management procedures.
Interacts with staff across multiple our Company sites.
Primary Activities include but are not limited to:
Develops detailed project plans for the collection, review, and cleaning of all clinical data for assigned trials within a specific drug / vaccine program.
Data includes, but is not limited to, case report form (CRF) data, lab data, biomarker data, and patient reported outcomes.
Serves as project manager of all clinical data management activities for trials as assigned.
Under the guidance of more senior staff when appropriate, uses excellent interpersonal, negotiating, and project management skills to perform and manage the following tasks:
Project planning, initiation, execution, change control, and closing.
Project team development, project team leadership, meeting management, and resource coordination.
Risk management planning (ie, risk identification, analysis, response planning, monitoring, and control), including escalation as necessary.
Management of customer / stakeholder expectations; facilitation of cross-functional decisions.
Defines trial-level requirements for quality data collection and validation at the trial level.
Reads and interprets the clinical protocol from a clinical data management perspective.
Provides clinical data management input into trial design, as appropriate, ensuring operational feasibility.
Engages with key stakeholders and subject matter experts to assess complexity, define trial-level data management requirements and inputs (including timing), and confirm all data management deliverables and services required for a trial.
Ensures appropriate use of standards and project-level consistency of database design, data collection, and validation.
Facilitates assessment and processing of standards and change requests.
Approves trial-level data validation plan (including project and protocol specific data validation elements).
Manages trial-level data quality and completion of database lock and post-database lock activities:
Monitors overall status and quality of data being collected during the in-life portion of a trial.
Engages with key stakeholders and subject matter experts to refine data management tools and validation plans, as appropriate.
Ensures activities required to achieve database lock (or data extraction) are completed by appropriate, responsible functional area.
Ensures timely archival of trial data and documentation.
Ensures timely decommissioning of clinical data management technologies.
Accountable for ensuring the successful execution of delivery of data management services provided by external partners engaged for outsourced trials, as assigned.
Supports site and sponsor audits, as appropriate.
Identifies and supports improvements to data collection and data management processes and tools.
Required Education and Skills:
Candidates must be working towards a BA or BS degree, preferably in life sciences, computer science, or related discipline.
Candidates must be available to work full-time for up to (12) weeks beginning in May or June of 2022.
Candidates must have interest in learning Clinical Data Management.
Preferred Experience and Skills:
Candidates should have basic understanding of the clinical research process.
Candidates should have strong organization and management skills.
Candidates must be able to communicate effectively - orally and in written form - with technical and business areas.
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation.
Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
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 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 us-and start making your impact today.
FTP2022Current 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 another's 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:
Intern/Co-op (Fixed Term) Relocation:
No relocation VISA Sponsorship:
No Travel Requirements:
No Travel Required Flexible Work Arrangements:
Flex Time, Remote Work, Telecommuting Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
2 Requisition ID:
R137714.
Estimated Salary: $20 to $28 per hour based on qualifications.
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