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Clinical Trial Specialist

Merck


Location:
Rahway, NJ
Date:
08/16/2017
2017-08-162017-09-15
Job Code:
CLI006129
Merck
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Job Details

Job Title: Clinical Trial Specialist  - CLI006129

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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 


The Clinical Trial Specialist (CTS) 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. The CTS focuses on compliance, quality, timeliness and accuracy of trial and program deliverables, leveraging clinical expertise, project management and communication skills to ensure compliance, accurate and timely reporting (e.g. milestone dates, Trial Master File (TMF), clinical study reports (CSR), program annual reporting coordination and quality control-QC). Applying expertise in process and systems toward continuous improvement initiatives, IT system upgrades/investments, the CTS interfaces with key functional partners (internal and external) to optimize the working environment, tools and workflows. 

The scope of work includes related activities in support of the Translational Pharmacology (TPharm) clinical portfolio (>100 trials and program level deliverables conducted each year across multiple therapeutic areas) and ~100 clinical employees across TPharm. 

The CTS is responsible in partnership with the 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
    • Ensures timely and complete execution of trial level agreements and contracts (confidentiality-disclosure agreements-CDA, vendors, trial level samples and services). 
    • Site/CRO documentation, communication support
    • Contributes to inspection readiness with expertise and knowledge of global/local regulations and Good Clinical Practice (GCP), ICH, CFR 
    • Detecting and resolving quality issues, escalating to ECS or consulting TPharm Continuous Improvement-Innovation (CI2) group to arrive at the best solution. 
  • Report, manage and interpret information for the clinical trials, including to supervise the work for the following activities of the CTS group:
  • Completeness and accuracy across multiple business systems and tools (ESTAR-Early Stage Trial Tracking & Reporting, Trial Master File, SPECTRUM, RCAM)
    • Represent TPharm Clinical Operations (TPCO) for systems improvement efforts, recommendations on IT spend, user acceptance testing-UAT. 
    • Clinical Data Disclosure & Transparency posting (CDD&T) support
    • Assists in the preparation of investigator meeting materials
    • Annual reporting, Development Safety Update Report, Periodic Safety Update Report (DSUR/PSUR), IND update support
  • Seek and implement opportunities for continuous improvement and innovation in processes, systems, quality-compliance and training. Under the direction of the Continuous Improvement-Innovation Lead, represents TPCO on cross-functional strategic initiatives, acts as change agent, applies lean methodology to drive efficiencies in workflows. Makes recommendations for IT upgrades with functional area partners. Leverages expertise to identify areas of process breakdowns, assess situations and propose approaches that impact ability to deliver the clinical trial - with quality, on time and within budget. Collaborate with TPCO quality, process and training SMEs to share systems and process learnings in order to benefit the department. 
  • Serve as (Subject Matter Expert) SME for applications, tools and systems in support of clinical trial execution.



Qualifications

Education: 
  • Bachelor of Science degree (or BSN) and minimum of 7 years related* experience, OR Master’s degree and minimum of 5 years related* experience in health-related, life science or analytical related field with demonstrated experience managing cross-functional teams and projects
*e.g., clinical trial management

Required: 
  • Working knowledge of the applicable regulations including FDA Good Clinical Practices, ICH Guidelines, and understanding of other major regulatory agencies Regulations and Guidances.
  • Knowledge of drug development and clinical trial processes, including related standards and documents.
  • Comfortable working in systems and applications and learning new technology
  • Proven communication skills including global communications, communications to senior management, project teams and other project stakeholders.
  • Strong professional presentation skills.
  • Clear ability to influence and lead in driving change in the organization.
  • Collaborative problem-solving capabilities as part of a team.
  • Ability to translate strategic vision into tactical plans and manage the change required to execute. 
Preferred:

  • Experience managing others to higher performance 
  • Phase 1 clinical trial experience 


Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 

 

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.


 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            

            



Job Clinical Research (Non-M.D.)

Primary Location NA-US-NJ-Rahway

Other Locations NA-US-PA-Upper Gwynedd, NA-US-MA-Boston

Employee Status Regular

Number Of Openings 1

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