Senior Manager, Clinical Operations - Oncology

Halozyme Therapeutics   •  

San Diego, CA

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 90 days ago

This job is no longer available.

POSITION SUMMARY:

The Senior Manager, Clinical Operations will be responsible for managing aspects of the operations of an oncology clinical research program, which may involve multiple simultaneous clinical studies of all phases of clinical development (phases 1 - 4). This may include project planning, budgeting, resource management, preparing and negotiating Clinical Trial Agreements and budgets for study centers, participating in the selection and management of CROs for Clinical Operations, Data Management/ biostatistics and other vendors (e.g., central laboratory), initiating and tracking payments made to study sites and vendors, organizing and conducting Investigator Meetings, and making clinical presentations.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include but are not limited to:

  • Participate in developing study-related documents such as clinical protocols and protocol amendments, informed consent forms, case report forms (CRFs) and CRF completion guidelines, advertisement materials, etc
  • Ensure compliance with all applicable regulatory guidelines and GCPs
  • On-site clinical monitoring and/or co-monitoring with CRO CRAs
  • Act as cross-functional liaison to ensure study plans remain aligned across functional areas
  • Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
  • Exercise good judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results
  • Effectively manage aspects of multiple studies and/or programs at one time, with good prioritization and time management skills
  • Employ expertise in study center selection, pre-study qualification, initiation, routine monitoring, and close-out, and ability to complete these responsibilities in compliance with company SOPs
  • Obtain medical/scientific input for protocols from biostatistics, investigators, clinical experts, and scientific advisors
  • Identify, manage and supervise clinical CRO and consultant activities
  • Recommend and implement innovative process ideas that impact clinical trials management and cost efficiency
  • Work comfortably within a fast-paced and dynamic work environment, with a high level of autonomy, and ability to embrace change

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:

  • Participate in the preparation and writing of Investigator’s Brochures, SOPs, and clinical sections of INDs and IND Annual Reports, DSURs, NDAs
  • Accountable for review of clinical data listings
  • Participate in preparing SAE reports for IND submission and, if appropriate, for IRB submission
  • Contribute to the design and maintenance of central clinical files
  • Other duties as assigned

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

  • Minimum BA or BS with bioscience major; RN, PharmD, pharmacy degree, or equivalent with 8-10 years of pharmaceutical industry experience, including monitoring clinical studies with appropriate knowledge of GCPs and regulations (an equivalent combination of experience and education may be considered)
  • Oncology study management experience highly preferred.
  • Prefer experience with global Phase 3 or larger global Phase 2 studies
  • Project leadership experience
  • Domestic clinical trialexperience; international experience is desirable
  • Excellent interpersonal skills
  • Excellent knowledge of GCP compliance issues
  • Computer/word processing expertise

TECHNICAL KNOWLEDGE REQUIRED:

Equipment:   PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained.  Knowledge of other equipment required: NA

Software Knowledge:  Windows, MS Office (Word, Excel, PowerPoint, Outlook).  Knowledge of other software required: EDC systems such as RAVE, Oracle Clinical, etc.

INTERNAL AND EXTERNAL RELATIONSHIPS:

  • Effectively interface with other line functions within Halozyme (e.g., Regulatory Affairs, CMC, Commercial, Project Management, etc.)
  • Build strong relationships with external parties, such as key opinion leaders and clinical investigators

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