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Scientific. Clinical. Software Engineering

Clinical Research Study Leader

New Jersey All, NJ

Job Type: Clinical Job Number: JN -052020-26822 Region: New Jersey All

Job Description

  • Leads the cross-functional Study Management Team (SMT)
  • Responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting
  • Prepares and manages the budget/financial plan including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking
  • Identifies key milestones and tracks critical study activities, issues and strategic priorities
  • Provides regular updates as appropriate, to key stakeholders
  • With SMT partners, ensures the development of study protocols in conjunction with SMT members, case report forms (CRFs) with Data Management, and necessary regulatory documentation following the provision of clear objectives
  • Conducts protocol and site feasibility assessments to ensure optimal site selection
  • Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site initiation, training, monitoring, essential document management, closedown and archiving
  • Proactive management of all aspects of the study
  • Manages both internal and external partners
  • For outsourced studies, contributes to CRO selection activities and contract set-up, serves as primary contact with CRO PM and provides oversight of CRO, ensures communication between CRO, other vendors and SMT for the entire study lifecycle
  • Assures consistency and standards across a study or studies for all investigational sites and in line with project standards
  • Works with Pharma Development Quality Assurance as appropriate to ensure that studies are conducted to appropriate levels of quality
  • Ensures that all adverse events are documented and that serious adverse events are processed and reported according to current SOPs
  • Reviews study data listings for accuracy, discrepancies and formatting throughout the study and prior to inclusion in regulatory documentation and clinical study reports
  • May provide support and mentoring to other CRSLs
  • Where appropriate, accountable for planning, tracking and managing the operational budget, resources and timelines for the project against the agreed goals of the team

Skills:

  • Strong leaderships and motivational skills developed through leading successful global multi-functional matrix study teams through all stages of clinical studies
  • Demonstrated consistent achievement of team delivery against commitments and goals
  • Experienced project manager, having led the development and implementation of risk management plans, managed complex study budgets and resourcing plans
  • Proven experience of all aspects of clinical studies including vendor/CRO management, leading/working as part of a HQ development team and coordinating study level activities to deliver data for filing or publication purposes
  • Experience of influencing and negotiating at all levels to achieve team delivery
  • Self-motivated and achievement driven
  • Excellent written and verbal communications skills

Competencies:

  • Project Management
  • Decision Making
  • Collaboration and Teamwork
  • Influencing
  • Cost and Financial Awareness

Job Qualifications:

  • Bachelors or Advanced degree or equivalent in a biomedical or life sciences discipline
  • Minimum 5-10+ years of Clinical Project Management experience at a pharmaceutical/biotech company
  • Extensive experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studies (with Early Phase studies)
  • Sound understanding and appreciation of the scientific basis for different study types, ability to question scientific rationale and practical aspects of protocol design and to act as an equal partner for scientific team members
  • Capability representing the Study Management Group at Clinical Teams
  • Highly developed interpersonal skills and demonstrated business awareness
  • Effective leadership skill to lead cross-functional teams across multiple time zones
  • Highly effective verbal and written communication/presentation skills in English
  • Effective team work and interpersonal skills (globally, internally and externally) including coaching and mentoring
  • Critical reasoning skills including the identification and resolution of complex problems
  • Proactive management of risk mitigation strategies to troubleshoot foreseeable consequences to a variety of decisions made by a team or an individual
  • Direct experience overseeing multiple vendors
  • Global experience


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