Position: Clinical Project Manager
Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
The Clinical Project Manager is responsible for the planning, implementation, execution and management of clinical research studies. Assist in clinical outsourcing to CROs and other vendors such as labs, IRBs, etc. May author, review and approve various study related documents and plans. Evaluates issues, interprets data, and suggests and implements solutions and mitigation as required. Responsible for the financial management of a study, and develops and oversees study timelines.
- Leads North American based clinical trials. May manage multiple small, early phase programs. Collaborates on global clinical trials
- Represents the study team to design, develop, execute and deliver the clinical study in accordance with the clinical development plan/strategy and timelines.
- May author/ review/ contribute to clinical study documents.
- Reviews and approves study related plans generated by Clinical CROs and vendors
- Assists clinical lead during regulatory inspections.
- Executes the clinical study in accordance with the project clinical development strategy, study plans, timelines and applicable regulations and guidelines.
- Collaborates with Data management for the preparation, clinical review and/or approval of Case Report Forms, User Acceptance Testing (UAT), and provides clinical input into corresponding completion guidelines.
- Responsible for oversight of identification and selection of investigator sites.
- Assists in for planning and conducting investigator’s meetings in cooperation with the respective departments.
- Responsible for content, accuracy and maintenance of study files (TMF, etc.) and ensuring the inspection readiness of the trial.
- Ensures accuracy and information provided in clinical registration websites (www.clinicaltrials.gov)
- Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
- Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
- Trains and manages CRO and other clinical vendor activities to ensure the quality meets Karyopharm and regulatory requirements.
- Performs periodic visits to sites and/or CROs to assess progress of studies/protocol compliance.
- Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required (including budget, deliverables and timeline metrics).
- Collaborates with the cross functional teams on clinical activities (drug supply, resolution of data queries, etc.) and on selection and management of clinical vendors.
- Reviews study monitoring reports in accordance with monitoring plan timelines
- May review budgets and contracts with CROs, vendors, and investigative sites, as applicable.
- Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
- Supports department initiatives and process improvements.
- Mentors other Clinical Operations staff (e.g. CTAs, CTMs, etc.).
- May attend relevant symposia, conferences and scientific meetings, as necessary.
- Provide support and potential identification of training needs across Clinical Operations and may support the creation, development and potentially provide training support to meet those needs. This includes any lessons learned sharing across the project team members.
- Up to 20% domestic and/or international travel may be required.
- Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred, but not required.
- Experience (6+ years) working in relevant clinical research preferably in clinical operations within a pharmaceutical company or CRO or similar organization.
- Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
- Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands.
- Ability to work/communicate successfully within a cross-functional team.
- Strong knowledge of applicable computer and project management software packages.
- Familiarity with financial budgeting and forecasting or reporting.
- Excellent written and oral communication skills.
- Strong interpersonal skill set to interact with investigators, vendors, and individuals at all levels of the organization.
- Working knowledge of current global regulatory requirements and guidelines governing clinical research and GCP
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