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Clinical Project Manager

Date: Aug 9, 2019

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Summary

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

 

SUMMARY

As a member of the Clinical Research and Operations Team, the Clinical Project Manager is responsible for operational planning and oversight of all study activities and escalates issues when needed from study concept through finalization of clinical study reports.  S/he will collaborate with cross functional teams to execute clinical study protocols, develop and manage clinical operational, project and study management plans while adhering to budget, scope and schedule requirements.  S/he will develop study performance matrix and management plans.  S/he will manage the project activities including but not limited to: clinical monitoring, data management, statistical analysis, medical writing, safety monitoring and compliance to insure proper conduct and timely completion of all projects.

Responsibilities
  • Manage all clinical aspects of the clinical program including:
    • Plan, execute and manage all aspects f multi-center global clinical trials  in cmpliance with GCPs, SOPs, and within designated program budgets and timelines;
    • Develp (but not limited to) the following program-specific documentation:
      • clinical development plan
      • program timeline and budget
      • risk management plan
      • educational/training plans
      • KOL/advocacy engagement plan
      • publication and congress plan
    • Develp (but not limited to) the following study-specific strategy tools and processes:
      • investigator/site/country/patient recruitment plans
      • request for proposal [RFP] process
      • vendor specifications
      • communication plans (including site and sponsor communication as well as site escalation)
      • ongoing data review plans
      • risk management plans
      • study timeline and budget
      • educational/training plans
      • publication and congress plan
      • performance and compliance metrics
Responsibilities Continued
    • Cllaborate with Legal department and/or clinical research organizations [CROs] to ensure timely review of the confidential disclosure agreements [CDAs] and clinical trial agreements [CTAs];
    • Create and manage clinical prgram/study budgets in conjunction with function head, Project Management and Finance;
    • Represent clinical study team fr study planning and maintenance activities with external vendors
    • Supprt selected investigative sites for IRB/IEC submissions, regulatory document collection and review, and budget and contract negotiations in collaboration with Legal and CROs;
    • Manage and reslve study conduct issues (including protocol deviations, data queries, SAEs/AEs, laboratory discrepancies, and archive reconciliation activities) as applicable;
    • Plan, execute, and lead study-specific meetings (e.g., Study Management Team [SMT], investigatr meetings, advisory committee, etc);
    • Prvide study-specific training and leadership to internal staff, CRO, sites, and other contract personnel;
    • Prepare and present prgram debriefings, as required.
Responsibilities Continued
  • At the discretion of the function head, perform periodic site monitoring and vendor audit activities in accordance with protocol, monitoring plan, and ICH-GCP guidelines including:
    • Perfrm Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-out Visits according to applicable company standard operating procedures [SOPs], regulations, and requirements of ICH-GCP;
    • Cmplete visit report and investigator correspondence documenting visit progress and issue identification and reconciliation;
    • Adequate fllow-up with investigative sites as needed to ensure the identified study conduct issues are resolved and reconciled.
  • Participate in and lead departmental initiatives as requested.
  • Contribute to SOP development
Requirements
  • A minimum of 5 years of related clinical trial and site monitoring experience with the last 3 years of experience in Pharmaceutical, Biotech or CRO company. 
  • Experience in operationalizing clinical trials in Rare Disease preferred (minimum of 1-2 years of recent experience). 
  • Candidates must have proven track record for delivering multi-center global clinical projects within time, budget, and quality expectations.
  • A minimum of a Bachelor’ s degree in a scientific discipline or equivalent  RN/BSN nursing degree (other majors considered with relevant work experience); advanced degree preferred
Competencies
  • ICH-GCP and FDA regulatory requirement understanding and competency.
  • Strong clinical study management skills, including risk assessment and contingency planning.
  • Ability to approach assigned duties in a highly organized, detailed and accurate manner. 
  • Ability to manage multiple priorities and work in a flexible, dynamic, and fast-paced environment.
  • Excellent leadership, oral/written communication, organizational, problem solving, conflict resolution, and team building skills.
  • Willingness to travel as dictated by assigned project requirements (approximately 25%). International travel may be required.
  • Ability to work cross-functionally with other departments involved in the conduct of a clinical study.
  • Ability (experience preferred) to work with cross-cultural teams including personnel from global locations as required per project with a positive attitude.
  • Microsoft Project, Office, PowerPoint and Excel proficiency.


Nearest Major Market: Philadelphia

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