Clinical Project Manager

March 29

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Karyopharm Therapeutics Inc.

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Karyopharm Therapeutics Inc. is a commercial-stage pharmaceutical company dedicated to pioneering novel cancer therapies. Driven by a belief in the extraordinary strength and courage of cancer patients, the company focuses on scientific innovation to develop potentially life-changing treatments for cancers with high unmet medical needs. Karyopharm is at the forefront of Selective Inhibitor of Nuclear Export (SINE) technology, addressing fundamental mechanisms of oncogenesis through ongoing clinical trials for various types of tumors, including hematologic malignancies and solid tumors.

oncology • pharmaceutical • biotech • multiplemyeloma • lymphoma

201 - 500 employees

Founded 2008

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🧬 Biotechnology

📋 Description

• Responsible for operational aspects of planning, implementation, execution, and management of one or more clinical research studies. • Ensure clinical trial is completed within established timelines and of the highest quality. • Oversee management of CROs, and third-party vendors to ensure work performed is in accordance to the Statement of Work and within the approved budget. • Authors, reviews, and approves various study related documents and plans. • Proactively evaluates study risks and works cross functionally to implement solutions and mitigations as required. • Responsible for the financial management of assigned studies and develops and oversees study timelines in coordination with cross-functional team, COL, and Program team. • Ensure inspection readiness from a global level by engaging trial team(s) and other stakeholders, with a focus on the Trial Master File (TMF) and general clinical preparedness. • Responsible for ensuring that inspection lessons learned are captured and shared. • Ability to appropriately escalate issues that are unresolvable at a study team level to the COL and other leadership as applicable.

🎯 Requirements

• Bachelor’s degree or nursing qualification is required. • Scientific/health care field preferred. • Experience (6+ years) working in relevant clinical research, preferably in clinical operations within a pharmaceutical company or CRO or similar organization. • Strong 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. • Superior organization skills. • Strong attention to details in composing and reviewing/editing materials. • Excellent analytical and problem-solving skills. • Ability to establish priorities, scheduling, and meeting deadlines. • Strong written, oral communication and presentation skills and ability to present at Team meetings. • Ability to reason independently and recommend specific solutions in clinical settings. • Ability to work successfully within a cross-functional team. • Strong aptitude with relevant technology platforms (e.g., eTMF, EDC, CTMS, IRT/IVRS) and project management software programs.

🏖️ Benefits

• 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 PTO 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