Careers

Manager / Senior Manager, Clinical Science

Full Time
74 E. Swedesford Rd, Suite 100, Malvern, PA, US
2 weeks ago | Requisiton ID:1038

The Manager/Senior Manager, Clinical Science will be responsible for leading or supporting the execution, and reporting of clinical trial activities for Phase 1 to 3 clinical trials, ensuring adherence to study timelines, budgets, Quality Plans and applicable FDA/ICH/NIH guidelines. This role liaises with vendors and partners as needed, directing CRO management and oversight of outsourced clinical activities.

Responsibilities include:

  • Contributes to the writing and/or reviews protocols, protocol amendments, informed consent forms, annual reports, investigator’s brochure, and regulatory submission documents.
  • Participates in interim reporting requirements to DSMBs and NIH.
  • Participates in the development of outsourcing strategies, including the selection of CRO’s and other external vendors, the development of clinical trial budgets, and issue escalation.
  • Manages/monitors clinical study activities and execution by the CRO’s.
  • Participates in the development of EDC and IWRS specifications for the clinical studies
  • Responsible for leading an internal trial management team, to ensure that all studies are carried out according to the study protocol, SOPs, applicable GCP/ICH guidelines.
  • Contributes to development of proactive strategy and corrective action plan to address trial issues in collaboration with cross functional team.
  • Participates in clinical operations process improvement initiatives to address clinical needs (e.g., development of investigator database, standardized CRF modules, etc).
  • Presents trial operations topics at investigator meetings and study team training meetings.
  • Ensure inspection readiness at all times for assigned trials

Qualifications:

  • B.S/B.A. degree in a science-related field
  • 5-7 years of clinical research experience, including clinical trial execution and reporting with progressively increasing clinical research experience and direct experience with pharmaceutical, biotech, and CROs
  • Must have experience with study management of international trials
  • Experience with anti-infective trials preferred
  • Familiarity with data management, as well as electronic data capture tools and 21CFR11 requirements
  • Excellent knowledge of ICH/GCP guidelines
  • Proficiency with and ability to utilize software applications that support Clinical Operations: Microsoft Word, Excel, PowerPoint; Adobe Acrobat, electronic data capture (EDC) systems, clinical trial management systems (CTMS) and electronic trial master file (eTMF)
  • Strong medical/scientific writing skills
  • Experience participating in authoring of and/or review of protocols and clinical sections of clinical documents
  • Demonstrated organizational and time management skills 
  • Excellent interpersonal communication skills, and demonstrated ability to prepare and deliver verbal presentations which are clear, focused and concise
  • Demonstrated teamwork skills, including cooperation, willingness to learn from others, and the ability to share relevant information
  • Experience anticipating and addressing key technical and operational problems in clinical research that could impact the broader process or team
  • Up to 20% travel may be required

                             Equal Employment Opportunity/M/F/disability/protected veteran status