Job Description

Clinical Capabilities Manager
Job Number: 21-08379
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Clinical Capabilities Manager for our client in Summit, NJ
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
 
  • Provides clinical and scientific support to the cross therapeutic area Clinical Development Organization with processes, systems and tools utilized in clinical trials.
  • The CCA supports the CCL (clinical development lead) and may serve as the primary contact and advisor for Clinical capabilities within the Clinical Development organization.
  • This role works closely with cross-functional partners, including Vendors and CROs, to ensure continuous improvement of processes and highest quality standards.
 
Responsibilities:
 
  • Support the review of procedural documents (SOPs, WIs, Job Aids) utilized by the clinical development organization and ensure alignment with the clinical leadership team.
  • May serve as the process lead and or SME for clinical owned processes (e.g. Clinical Protocol, DMC, SSC, Protocol Deviations, safety narrative review etc)
  • Support assigned projects with supervision by manager
  • Represent Clinical during inspections and audits, and with responses and CAPA resolution for clinical development related findings.
  • Determine root cause and corrective actions for platforms and systems that affect Clinical processes and efficiencies (e.g., protocol deviation process, CTMS); lead implementation efforts.
  • Lead work streams for a large global GCP Quality Management Systems (QMS) Optimization project as it relates to clinical processes
  • Support the maintenance of the clinical scientist/clinical trial physician onboarding program for new employees.
  • Support the CCoE learning sessions and trainings to the clinical development organization in partnership with R&D Learning.
  • Support coordination and agenda management of CCoE leadership meetings.
  • Attend and lead team meetings as needed for assigned projects
  • Interface with clinical and other functions for scientific and functional guidance
  • Identify & escalate current/active issues to manager
  • Enact best practices with instruction
  • Contribute to CCoE and cross functional continuous improvement initiatives
  • Actively seek and receive coaching/mentoring
  • Provide regular and timely updates to manager
 
Required Skills:
 
  • Awareness of GCP/ICH, drug development process, study design, statistics
  • Excellent verbal, written, communication, and interpersonal skills
  • Detail-oriented
  • Entry level knowledge of clinical development roles and responsibilities
  • Entry level Experience in SOP writing and process development
  • Demonstrate critical thinking & problem-solving skills
  • Exhibit Commitment to Quality
  • Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
  • Skilled in Microsoft Word/Excel/PowerPoint/SharePoint
  • Ability to quickly learn clinical research systems
 
Qualifications:
 
  • Degree in Life Sciences
  • 2 years of experience in CR&D roles/responsibilities or equivalent
  • 2 years of experience in clinical science, clinical research, or equivalent
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
Jane Bautista
froilyn.bautista@eclaro.com
2012858622
Jane Bautista | LinkedIn
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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