Senior Clinical Trial Manager

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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