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.
- 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.