Senior Clinical Trial Manager

Highly Competitive Salary
  1. Permanent
  2. Clinical Trial Assistant (CTA), Project/Study Manager (CSM/CPM), Program Manager / Director
  3. United States
Philadelphia, USA
Posting date: 09 Jun 2020
CR.SC.29894

Proclinical is currently recruiting for Senior Clinical Trial Manager with a global biopharmaceutical company located in Philadelphia, PA. Successful candidate will be responsible for ongoing management of a clinical study by planning and executing operational aspects throughout the lifecycle of a project. The CTM will work closely with individuals/departments within and outside the clinical operations department.

Job Responsibilities:

  • Interface with Regulatory/Safety, Clinical Supply Chain, and Data Management in the planning, execution, and maintenance of clinical studies.
  • Monitor project timelines and resources.
  • Coordinate and lead cross-functional project team meetings.
  • Facilitate protocol, Informed Consent Form template and Case Report Form development.
  • Manage and provide oversight to internal and contract CRAs, including approval of site monitoring reports.
  • Ensure study is conducted according to GCP/ICH standards and internal SOPs.
  • Plan, coordinate, and present at investigator meetings.
  • Create and implement study project plans where applicable.
  • Participate in CRO and vendor management (if applicable) and budget oversight.
  • Assist in establishing study budgets and participate in site contract/budget negotiations and budget maintenance throughout the study.
  • Oversee clinical supply requirements, such as forecasting, site shipments, and returns/reconciliation.
  • Coordinate and manage the flow of documents related to the planning and conduct of clinical trials; this includes solicitation and acquisition of completed documents from internal and external stakeholders, organization and archiving of documents, retrieval of documents, and tracking and distribution of documents.
  • Assist in the compilation of documents to support submission to regulatory agencies, institutional review boards, oversight committees, grant funding agencies, and auditors.
  • Communicate with research site personnel, oversight committee members, field-based personnel supporting clinical research, and contract research organization personnel.
  • Assist in the planning and coordination of meetings related to clinical trials.
  • Support activities related to site and staff training.
  • Learn relevant Company policies and procedures and perform duties in compliance with those procedures.

Skills and Requirements:

  • Bachelor's degree in a scientific discipline
  • Minimum of 5 years industry experience in clinical research with good knowledge of GCP/ICH principles.
  • Possess strong oral and written communication skills.
  • Ability to multi-task and have good organizational and administrative skills.
  • Familiarity with MS Project required.

If you are having difficulty in applying or if you have any questions, please contact Susan Chapman at (+1) 646-542-0158.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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