Manager, Clinical Trials (DB1206)
Therapeutic Proteins International, LLC - Chicago, IL

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SUMMARY:
The Manager, Clinical Trials (MCT) is part of the Clinical Operations department reporting to Compliance. The MCT will act as the function lead from Clinical Operations with responsibility for delivery of all Clinical Operations aspects of clinical studies ensuring consistency with procedures, studies and budgets. The MCT will oversee and manage the conduct of global clinical trials at the regional level for all clinical phases (pre-clinical, I-IV) using in-house resources and CROs.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Primary point of contact for Clinical Operation aspects of the organizations clinical study programs
  • Responsible of planning, scheduling and implementing the Clinical Operations for clinical study programs
  • Responsible for vendor selection and management including CRO, IVRS, central lab and imaging vendors
  • Lead the Study Management Team (SMT) including representatives from Medical, Biostatistics, Data Management, Clinical suppliers, Regulatory, Pharmacovigilance, Medical Outsourcing, Regional Clinical Operations, and other relevant departments
  • Interface with Medical Outsourcing and Purchasing regarding contract services. Ensure SMT participation in the development of study specifications/scope of work/project timeline for Request for Proposal (RFP) development. Ensure SMT participation in bid defense, vendor selection and contract finalization meetings
  • Assist in selection of centers for clinical studies
  • Prepares recruitments projections and assures that these are met with the CRO or internal teams
  • Submits reports to upper manage regarding the progress of the trials
  • Develops an in-depth medical knowledge in relevant indications
  • Work with the Clinical Supplies Liaison and Medical Director to forecast and maintain adequate Clinical Supplies.
  • Ensure timely distribution of Dear Investigator Letters (DILs)
  • Ensure study timelines are met, oversee that study progress is reported and tracked, results and any significant findings are discussed with the SMT and ensure that the study status within the clinical trial tracking databases are maintained
  • Communicate with Investigative sites regarding study progress issues, communicate regularly with contacts within Joint Venture organizations, when appropriate, and communicate study progress/status on a regular basis to upper management
  • Assure the proper study documentation is maintained and archived in the
  • Facilitate and actively participate in process improvement initiatives, taskforces and committees within Clinical Operations and cross-functionally

PREREQUISITES
Education:

  • Minimum a bachelor’s degree from a four-year university/college in scientific discipline.

Experience:

  • Minimum of 2 years of active clinical trial monitoring experience as a Clinical Research Associate (CRA)
  • At least 5-7 years experience in clinical trial management
  • Industrial experience desired (CRO, Biotech, Pharma)
  • Knowledge and understanding of ICH GCP and relevant regulations in US and EU for conducting clinical trials
  • Understanding of data management and statistics and the application to clinical trial management
  • Therapeutic Experience: Oncology or Multiple Sclerosis
  • Ability to effectively organize and prioritize tasks to achieve established deadlines
  • Ability to manage multiple projects
  • Strong verbal and written communication skills
  • General technology skills

Certifications, Licenses, etc.:

  • Certification in Project Management from an accredited institution is desired
  • Certification in Good Clinical Practices (GCP) is desired

SPECIALIZED KNOWLEDGE AND SKILLS:
Language:

  • Must read, write, speak English

Mathematical Skills:

  • Must be able to apply basic mathematical skills for addition, subtraction, multiplication, and division
  • General statistical calculations using Excel or other statistical programs

Reasoning Skills:

  • Relies on experience and judgment to plan and accomplish goals.

Computer and/or Technical Skills:

  • Experience with Project Management Software programs
  • Operation and understanding of word processing, spreadsheets, and data management

WORK ENVIRONMENT AND PHYSICAL DEMANDS:
General Work Environment:

  • Office environment

Noise:

  • Standard noise levels in an office

Standing/Lifting:

  • No special requirements

Visual:

  • No special requirements

Stress:

  • High paced demanding environment to meet the Regulatory needs of the company

Travel:

  • Travel will be expected, but not to exceed 40%

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