at Merck in Augusta, Maine, United States
Job Description
Job Description
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Translational Medicine is responsible for early clinical development of novel therapeutics, working in close collaboration with Discovery Sciences and late-stage Clinical Research across all therapeutic areas. Our team is focused on innovation and dedicated to translating breakthrough science into innovative medicines that extend and improve the lives of patients worldwide. Through clinical trials, we ensure the safety and efficacy of our pipeline and existing products to produce safe, effective, innovative medicine.
The Clinical Trial Specialist partners with the early development clinical study team in the planning, execution, closeout, and reporting activities for clinical trials and is accountable for delivering selected critical-to-quality tasks.
Primary Responsibilities:
+ Focus on compliance, quality, timeliness and accuracy of trial and program deliverables, leveraging clinical expertise, project management and communication skills to ensure compliant, accurate and timely reporting (eg, milestone dates in the Clinical Trial Management System (CTMS), Trial Master File (TMF), Clinical Study Reports (CSR)
+ Partner with clinical team for site/CRO ready (planning) through trial closeout and reporting deliverables, including the following activities:
+ Collection/approval of essential documents
+ Systems provisioning and milestone data entry
+ Drug and ancillary supplies management
+ Clinical Study Report assembly, accuracy and quality control reviews
+ Ensure timely and complete execution of trial level agreements and contracts (Confidentiality Disclosure Agreements (CDAs), consultant, vendors, trial level samples and services)
+ Contribute to inspection readiness with expertise and knowledge of global/local regulations, GCP, and ICH guidelines
+ Detect and resolve quality issues, escalating to clinical scientist or consulting other functions (eg, Quality, Legal, Compliance, etc.) to arrive at the best solution
+ Report, manage, and interpret information for clinical trials to ensure completeness and accuracy across multiple business systems and tools (ESTAR-Early Stage Trial Tracking & Reporting, TMF, CTMS, RCAM)
Education Minimum Requirement:
+ Degree in Life Sciences
+ Bachelor’s degree and =4 years related* experience, OR
+ Master’s degree or higher and =3 years related* experience
+ *eg, knowledge of clinical trial management and trial execution; experience in health-related, life science or analytical related field with experience managing cross-functional teams and projects
Required Experience and Skills:
+ Knowledge of GCP, ICH guidelines, and regulatory requirements
+ Knowledge of drug development and clinical trial processes, including related standards and documents
+ Ability to partner effectively with internal and external teams to achieve results
+ Strong team collaboration, leadership, and communication (written and verbal) skills
+ Ability to identify issues and develop mitigation plans
+ Ability to manage/track milestones and deliverables for multiple projects at a time
Preferred Experience and Skills - Global Phase 1 clinical trials experience
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And 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.
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.
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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.
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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)
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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 another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:
$80,320.00 – $126,500.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .
