Senior Clinical Trial Manager job in Philadelphia, USA

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First Name*

Last Name*

Email*

Phone Number*

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Phone Number*

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Job type: Permanent

Discipline: Clinical Trial Assistant (CTA), Project/Study Manager (CSM/CPM), Program Manager / Director

Location: United States

This vacancy has now expired. Please see similar roles below...

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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