Senior Project Manager

Kapadi Pty; United States; On-site; USD 155,000 - 165,000; Full time

Job summary

Kapadi Pty is seeking a Senior Project Manager to lead interdisciplinary oncology clinical research studies in a CRO setting. You will act as the main liaison with customers and manage timelines, site data, risk plans and quality across multiple partners.

The role requires 5+ years in clinical R&D (CRO preferred), oncology experience, and strong knowledge of GCP/ICH guidelines. Degree in Life Sciences or related field is required. US work authorization is needed, with salary range disclosed.

Qualifications

• Bachelor’s degree in Life Sciences, Medicine, Pharmacy, Nursing or equivalent.
• 5+ years of clinical R&D experience in pharma/biotech/CRO environments.
• At least 2 years of CRO experience with clinical monitoring oversight.
• Oncology experience; immuno-oncology and cell therapy preferred.

Responsibilities

• Manage a project overseeing interdisciplinary clinical research studies.
• Act as a primary liaison between Kapadi and the customer to ensure timely study initiation, conduct, and closeout.
• Lead a project team and oversee quality of clinical monitoring, timelines and site management deliverables.
• Be accountable for the financial performance of each assigned project.
• Coordinate activities and deliverables of study conduct partners and manage issues.

Skills

Leadership

Vendor management

Clinical R&D

Oncology expertise

GCP/ICH knowledge

Regulatory awareness

Education

Bachelor’s degree in Life Sciences/Medicine/Pharmacy/Nursing

Tools

Analytical dashboards

Site Assessment Reports

Job description

Kapadi is a full service CRO that focuses on complex oncology indications including immunotherapy and cellular therapies. We know that innovative research requires innovative operations and we've built that into our culture, systems and processes. We have an infrastructure to enhance access to patients and integrated technology to provide higher quality and faster access to results. We are looking for a highly-motivated Senior Project Manager to help us continue to grow our business and deliver new, life-changing therapies for the cancer patients who need them.

As a Senior Project Manager, you will:

• Manage a project overseeing interdisciplinary clinical research studies.
• Act as a primary liaison between the company and the customer to ensure timely study initiation, conduct, and closeout according to the customer’s and the company’s contractual agreement, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively.
• Lead a project team and oversee quality of clinical monitoring, timeline and site management deliverables.
• Be accountable for the financial performance of each assigned project.
• Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
• Review study and site data listings and visualizations via analytical dashboards and/or reports to identify trends, risks, and suspected scientific misconduct on other systematic errors that could impact data integrity and subject safety.
• Drive risk identification and risk monitoring strategy cross-functionally, ensuring that appropriate risk monitoring tactics are written into the CMP, and be accountable for the clinical team’s understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP, and risk plans.
• Create and maintain relevant project plans.
• Routinely review clinical systems, dashboards, and documentation (e.g., Site Assessment Reports) to oversee site and study team conduct and identify any risks to delivery or quality.
• Possibly participate in customer proposal development and bid defenses.

Knowledge, skills and abilities:

• Demonstrated knowledge of the clinical research and development process in pharmaceutical and/or biotechnology industries.
• Demonstrated knowledge of oncology therapeutic area.
• Demonstrated ability to lead multidisciplinary teams of professionals, including vendor management.
• Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.

Requirements:

• Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
• Minimum of 5 years of experience in clinical R&D in pharmaceutical, biotechnology and/or clinical research organization (CRO) businesses, including at least 2 years of experience in a CRO providing clinical research services to pharmaceutical, biotechnology or medical device companies, and including at least 2 years of clinical management experience (i.e., oversight of CRAs).
• 5 years of oncology clinical or research experience preferred. Immuno-oncology and cell therapy experience also required.

The anticipated salary range for this role is $155-165k/yearly with bonus potential. Actual compensation will depend on experience, location, and other factors.

Candidates must be authorized to work in the United States without current or future sponsorship.

We are an equal opportunity employer and are committed to creating an inclusive environment for all employees. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected characteristics.