Job Description

Clinical Site Lead / Clinical Research Manager
Job Number: 21-14986
 
Be a part of a company that supports life-changing healthcare solutions. Eclaro is looking for a Clinical Site Lead / Clinical Research Manager for our client in NJ.
 
Eclaro’s client is a leading manufacturer of lab materials, technology and service supporting the Life Science field. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Responsibilities:
  • Establish and manage site relationships, including but not limited to:
    • Act as liaison between the company and investigational sites, building investigator and site staff awareness on client’s compounds
    • Develop and implement a plan, in collaboration with global and local teams, to raise the profile of the company and its global clinical development projects with current and potential investigators
    • Independently perform activities associated with the evaluation of investigational sites to build company network
    • Proactively work with Medical/Patient/Industry Associations to build company network and to promote company clinical trials
    • Develop knowledge of site capabilities and past performance to assess their potential as participating sites in client’s clinical trials
    • Ensure regular communication with local organization to align interactions with TLs and other relevant stakeholders
  • Oversee site-level study start-up, conduct, and close-out activities outsourced to CRO(s) for global programs across Therapeutic Areas, including but not limited to:
    • Support Site Agreement negotiations, including stand-alone and Master Site Agreements
    • Identify trends, issues and risks across sites, and work with external vendors and internal Trial Team to resolve/mitigate those
    • Collaborate with external vendors and internal Trial Team, to ensure that sites are activated in a timely manner and according to agreed timelines
    • Collaborate with external vendors and internal Trial Team, to ensure that sites deliver on expected recruitment targets, including identifying reasons for non-recruitment, and identification of non-performing sites that require actions
    • Ensure ICH/GCP/local regulatory requirements are observed
  • Senior Manager, Clinical Site Lead: Provide documented sponsor site oversight at country level for outsourced trials in country under remit as required by regulation. Utilize site performance and quality data to optimize prioritization of oversight actions
  • Senior Clinical Site Lead: Drive documented sponsor site oversight at country level for outsourced trials in country under remit as required by regulation. Utilize advanced analytics to optimize prioritization of oversight activities
  • In addition, may be assigned one or more 'added value' roles:
  • Therapeutic Area Expert: SME with focus to increase disease knowledge within the team by sharing materials (training/articles/abstracts) and/or arranging training sessions
  • Country Start-up Specialist: Ensure that clinical sites in country(ies) of responsibility are activated within agreed timeframe and company agreed cycle times. Work closely with respective Clinical Site Leads to support them in issue resolution for site activation. Collaborate with external vendors to identify process(es) requiring improvement at the country level, build action plans to strengthen/improve those and track impact of action. Support OSM model by acting as a local SME
  • Clinical Trial Delivery Lead: Identify trends and issues within/across assigned trial(s) which may impact key deliverables (e.g. timelines/quality/costs) and implement action plans to either resolve and/or mitigate those. Advise the Trial Team on trends/issues and facilitate solutions, working closely with the lead  to ensure Corrective & Preventive Actions are defined and implemented. Raise awareness of such trends/issues with Clinical Site Leads and other internal and external stakeholders as appropriate, including Leadership. Develop, implement and follow up on strategic action plans to drive improvements in site activation and/or enrolment, in collaboration with the CTL, CRO(s) and working closely with the respective Clinical Site Leads: Participate in Investigator/Study Coordinator Meetings and promote information sharing with the Clinical Site Leads as needed
  • Clinical Site Leads: Manage company/department improvement initiatives as leadership role, with strategic impact and delivery accountability. Take the lead and be the business process owner of the expert area, responsible for:
    • Define process goals
    • Design and document business requirements
    • Ensure harmonization and standardization of the process
    • Act as interface between functional managers and process team
    • Ensure implementation of optimization measures
    • Process monitoring/controlling, analysis and continuous improvement
  • Has good organizational understanding, relevant product, Clinical research landscape knowledge and ability to leverage this expertise to achieve objectives
  • Interprets and anticipates internal and external business challenges and recommends best practices to drive process improvements
  • Is recognized as an expert within client and beyond; with peers within the same technical area in the business; as well as other key business functions
  • Serves as best practice resource within client, may also act as a technical expert on cross-functional teams or projects
  • Handles sensitive issues and guides, influences and convinces colleagues in other teams/functions as well as external partners
  • Impacts through successful execution of projects within client
  • Oversee external providers as applicable
  • Cooperation Internally: Functions, Early & Late Stage Dev OperationsDevelopment Unit Clinical Leads, (Global) Medical & Regulatory Affairs, R&D Quality, Other functions as needed
  • Cooperation Externally: Clinical Research trial sites (Institutions/Investigators), Ethics Committees/ Regulatory Authorities (e.g., ECs/IRBs), Hospital administration, Pharma Industry working groups, Vendors (CRO), Patient Associations
 
Required Qualifications:
  • Clinical operations, monitoring, project management, study coordinator experience, auditing experience
  • 8+ years experience in clinical operations in a CRO, pharma or biotech company including site management/oversight, and site-level clinical study conduct
  • Requires graduate background (Medical or Life Sciences degree) in a clinical research related discipline or equivalent work experience
  • Detailed understanding of all aspects of clinical protocol design and implementation, clinical site monitoring as well as overall global drug development
  • Expert knowledge of clinical development (principles and concepts as well as regulatory environment e.g. ICH GCP and applicable regional/local regulations)
  • Oncology and/or Neurology and/or Immunology TA experience desired
  • Experience and proven proficiency in CTMS and eTMF systems preferred
 
Skills:
  • Strong communication skills (verbal, written and listening)
  • Aptitude to interpret and to integrate site performance data in prioritization of oversight activities
  • Ensuring compliance with applicable T&E Policy requirements
  • Ability to work independently on assigned tasks or projects of increasing complexity
  • Capability to perform self-training incl. on therapeutic area, and synthesize the key take-away points for studies under remit
  • Sound negotiation skills and adapting to a variety of parties
  • Record of vendor interactions
  • Sound critical thinking skills and ability to understand complex patient histories, medical terminology and specific therapeutic area treatment landscapes
  • Detail-oriented, organized and committed to quality and consistency
  • Results driven and capable of managing competing high-priority assignments
  • Proven track record of achieving deliverables within specified timelines
  • Ability to work in a dynamic environment with a high degree of flexibility
  • Ability to communicate effectively with Key Leaders, site staff, and internal team members
 
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:
Chris Imbien
Chris.imbien@eclaro.com
8428729257
 
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.

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