Position: Senior 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 Senior Clinical Project Manager is responsible for the planning, implementation, execution and management of one or more clinical research studies. Manages 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/program, and develops and oversees study timelines.
- Represents and leads the study team to design, develop, execute and deliver the clinical study in accordance with the clinical development plan/strategy and timelines.
- Global clinical trial experience and the ability to lead/manage more than one clinical trial.
- Authors/ reviews/ contributes to clinical study documents.
- Reviews and approves study related plans generated by Clinical CROs and vendors
- Provides input as the subject matter expert for the study during regulatory inspections.
- Executes the clinical study in accordance with the project clinical development strategy and timelines.
- Accountable for the timely 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.
- Responsible for planning and conducting investigator’s meetings in cooperation with the respective departments.
- Ensure the delivery of clinical trial supplies in collaboration with the clinical supply team. Sr CPM
- Collaborates with the cross functional team on selection and management of clinical vendors.
- 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.
- Monitors the status of clinical data collection of assigned clinical studies.
- May perform 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.
- Evaluate site and study performance metrics against agreed upon budget, deliverables and timelines.
- Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans through regular investigator site / CRO / clinical vendor contact.
- Responsible for the availability and tracking all relevant study information/ study metrics
- Oversee the resolution of data quality issues.
- Reviews correspondence and monitoring reports relating to the study.
- Evaluates CRO and vendor performance for future work.
- Provides periodic status reports regarding study timelines, accruals, etc. to Karyopharm Management as requested.
- Reviews budgets and contracts with CROs, vendors, and investigative sites, as applicable.
- Requests and critically evaluates proposals and change orders from CROs and vendors.
- Leads team through selection process and provides input into contracts, change orders, and/or work orders. 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.
- May mentor other Clinical Operations staff (e.g. CTAs, CTM, etc).
- 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.
- May directly manage or line manage other clinical operations staff 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 (8+ 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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