Senior Project Management Specialist

📋 Description

• Facilitate site touchpoint meetings, document key updates, and coordinate subsequent actions to ensure timely patient progression and randomization.

• Collaborate cross-functionally with internal stakeholders to guarantee consistent and accurate guidance is provided to the sites.

• Manage and adjust patient journeys in real-time, considering individual needs and site limitations, while adhering to the defined V2V pathway.

• Propel end-to-end patient workflows to ensure rapid and compliant progression both before and after randomization.

• Coordinate essential milestones, including eligibility, randomization, and manufacturing timelines, in collaboration with internal teams.

• Offer clear guidance to sites regarding required EDC completion and assist in resolving issues, including communications about out-of-specifications.

• Act as a dependable and responsive point of contact for site stakeholders, with availability beyond standard hours.

⛳️ Requirements

• Bachelor’s degree in life sciences, medicine, pharmacy, health sciences, or a similar field.

• Over 3 years of experience in clinical operations, medical affairs, or a related role within immunology and/or oncology.

• Proven experience in coordinating cross-functional stakeholders and managing complex, time-sensitive projects.

• Established capability to interpret and implement clinical trial protocols while ensuring compliance in a regulated environment.

• Master’s degree in life sciences, medicine, pharmacy, health sciences, or a related field (Preferred).

• Experience in cell and gene therapy, especially in clinical development settings (Preferred).

• Proficient in project management methodologies and tools within clinical or regulated environments (Preferred).

• Familiarity with strategic planning, risk management, and change management (Preferred).

• Advanced problem-solving skills for complex operational challenges in regulated clinical environments (Preferred).

• Experience in coordinating cross-functional teams and fostering alignment among stakeholders (Preferred).

🏝️ Benefits

• Competitive rates for Health, Dental, and Vision Insurance.

• 4 weeks of vacation, provided at the start of each year and prorated for the first and last year of employment.

• 12 company-paid holidays.

• 7 days of sick leave.

• 100% employer-paid life insurance up to 1x annual salary, with a maximum of one hundred thousand dollars.

• 100% employer-paid short- and long-term disability coverage.

• 401(k) with immediate eligibility and company matching. The company will match 100% of your contributions up to 3% of your base salary for the first two years, 4% for years 2-3, and up to 5% of your salary starting from the fourth year of continued employment.

• Partially paid parental leave for eligible employees.

• Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, along with identity theft protection and pet insurance.