Responsible for supporting the Clinical Project Manager (CPM) with operational aspects of planning, implementation, management and tracking of the clinical trial activities and ensuring clinical trial deliverables are completed per established timelines and of the highest quality. Responsible for study start-up activities.  Direct management of CROs and other third-party vendors including proactively identifying any upcoming issues or risks to study deliverable and escalating to CPM and study team.  Maintenance of Trial Master File throughout the study lifecycle to ensure inspection readiness and assists with preparedness for audits/inspections. Tracking and reporting on study progress from start-up through close-out and bringing identified risks to the attention of the CPM and study team. Obtaining cross-functional information for Study Team Meetings as needed. Responsible for assigned close-out activities to ensure timelines are met and working with CPM and team to mitigate obstacles.

• Responsible for clinical trial start up activities including the development of study specific documents and, in coordination with CPM, the identification and selection of investigative sites as well as working with regulatory team to ensure submission requirements per country are met.
• Involved in the review of protocol amendments and ICF.
• In coordination with CPM and Lead Clinical Research Associate (LCRA), where applicable, works on the preparation of site and CRA training materials and presentations.
• Tracks and reports on progress of the study from start-up through close-out and proactively identifies risks and escalates issues to the CPM and study team.
• In coordination with the LCRA, where applicable, oversight of monitoring support activities and attend CRA meetings as needed.
• Involved in preparation/review of clinical trial materials throughout the lifecycle of the trial and able to identify where materials may require updating.
• Involved in the clinical review of Case Report Forms and IRT User Acceptance Testing (UAT) and the creation of study specific eCRF completion guidelines as needed.
• Along with CPM, responsible for content, accuracy, and maintenance of study files (TMF, etc.) and inspection readiness of the trial.
• Assists team in preparation for audits/inspections.
• Works with Clinical Supplies to ensure sites are provided with study required supplies and proactively identifies and communicates risks to the CPM and study team for discussion and resolution.
• Responsible for direct management of CRO and other vendors to ensure progress and proactively work to mitigate any identified issues and escalate to CPM and study team as needed.
• For studies not utilizing a CRO, contact sites as needed for data entry/data quality concerns and alerts CRA of any issues prior to the next scheduled monitoring visit.
• Responsible for assigned close-out activities, e.g., data cleaning activities, ensuring all activities at sites are completed prior to closure and communicating any risk to database lock timelines to CPM and study team.

• Collates data and prepares Clinical Study Report (CSR) documents as required.
• Provide mentorship to other Clinical Operations staff members.
• Additional activities and responsibilities may be assigned by the CPM as needed.
• Up to 20% domestic and/or international travel may be required.

• Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred.  Exceptions can be made for individuals with multiple years of experience in Clinical Operations.
• Experience (4+ years) working in relevant clinical research, preferably in clinical operations within a pharmaceutical company or CRO or similar organization.
• In-depth knowledge of clinical research processes and clinical research terminology.
• In-depth knowledge of ICH-GCP guidelines and local regulations.
• Knowledge of regulatory requirements and guidelines governing clinical research.
• Excellent organizational skills.
• Ability to proactively identify issues and risks and bring forward possible solutions to the study team.
• Strong attention to detail in composing and reviewing/editing materials.
• Good analytical, problem solving and creative thinking skills.
• Ability to establish priorities, manage schedule, and meet deadlines.
• Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands under tight timelines.
• Ability to work successfully within a cross-functional team.
• Ability to effectively interact with investigators, vendors, peers, and management.
• Strong aptitude with relevant technology platforms (e.g., eTMF, EDC, CTMS, IRT/IVRS) and project management software programs.

At Karyopharm, we live and demonstrate our ICARE values every day!

If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That’s why we’ve built an environment centered around support, flexibility, and a shared mission.

Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us – whether that’s onsite, from home, or anywhere in between.

What do you get when you pair an extraordinary mission with a culture of flexibility and empowerment? We invite you to find out and join us on this incredible mission.

Check out our Culture Video!

What We Offer:

In addition to our exciting, supportive, and intellectually challenging global workspaces(s), team members enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills.

• A culture of employee engagement, diversity, and inclusion
• Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!
• Peace of mind through best in class medical (deducible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), ESPP and tuition reimbursement.
• Wellness Program with a monthly stipend. 
• Generous Flex Time Off program and Holidays – we encourage you to recharge and spend time with family and friends.
• Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development & mentoring programs, and a variety of reward and recognition programs)
• Cell phone allowance