Clinical Trial Manager
CSPC Pharmaceutical Group Ltd (“CSPC”) is a premier Chinese Pharmaceutical company listed in Hong Kong Stock Exchange. Driven by oncology-dominated innovative product portfolio and international growth strategy. The Director, Clinical Operations will be responsible for, but not limited to following:
Conjupro Biotherapeutics, Inc. is a subsidiary company of CSPC Pharmaceutical Group Ltd (“CSPC”), a premier Chinese Pharmaceutical company listed in Hong Kong Stock Exchange. Driven by oncology-dominated innovative product portfolio and international growth strategy, Conjupro Biotherapeutics, Inc. is seeking a Clinical Trial Manager (CTM) to manage clinical studies under the direction of the Director/Senior Director Clinical Development. This position will be required to work onsite at the company’s Princeton location.
Essential Duties and Primary Responsibilities include, but are not limited to:
- Participate in study start up, study maintenance and close out activities of trials, as assigned.
- Assist in the management CRO, third-party vendors and sites.
- Responsible for ensuring development of, contributing to and/or writing of trial level project plans
- Establish working relationships with vendors and sites
- Ensure audit-readiness of clinical trials including sponsor oversight activities
- Responsible for TMF development, maintenance, quality checks and audit readiness
- Assist with the development and maintenance of study timelines, budgets and invoices.
- Review and provide inputs on clinical study data
- Ensure compliance with regulations, SOPs, ICH, GCP and FDA regulatory requirements
- Participate in quality assurance and CAPA activities.
- Coordinate resolution of audit findings
- Prepares and manages clinical documentation including but not limited to, action, decision and issue logs (ADI), tracking logs and reports.
- Serves as a central contact for communications/correspondence and associated documentation for identified activities.
- Manages and coordinates internal/external team meetings and internal/external investigator meetings.
- Management of vendor budgets and invoices.
- May support multiple trials under different Project Leads.
- Performs other duties as assigned
Education and Experience
- Minimum Bachelor’s degree in a scientific field or higher (preferred), or equivalent work experience.
- Minimum 3-5 years of trial management experience with a proven track record for delivering clinical projects within time, budget and quality expectations.
- Experience with study budgeting and invoice management.
- Adept with tracking of study activities and providing audit readiness support.
Skills
- Strong organizational skills with excellent attention to detail
- Excellent multitasking and strong problem-solving skills
- Excellent verbal and written communication.
- Strong knowledge and clear understanding of ICH, GCP and FDA regulatory requirements.
- Ability to handle high volume of work with tight deadlines.
- Proficiency in MS Office, including Word, Excel, Power Point and Project.
- Prefer higher level skill with MS Project and Excel.
- Able to work independently or in a group.
CSPS Pharmaceutical Group LTD is an Equal Employment Opportunity / Affirmative Action employer. Qualified applicants will receive consideration for employment without regards to race, color, religion, sex, or national origin.