Clinical Research Project Manager

The Company

A biotechnology company focused on the research, development and commercialization of novel cancer therapeutics in two principal areas:

1) Collateral Targeting Agents for the treatment of solid tumors and

2) direct tumor targeting agents for the treatment of refractory malignant lymphomas.

The company mission is to increase the quality of life of people suffering from cancer and to increase shareholder value by rapidly commercializing the platform technologies through in-house development, joint ventures, strategic alliances and licensing agreements.

Scope of the Job & Responsibilities:

The Clinical Research Project Manager reports to the Director, Clinical Affairs in the Clinical Affairs Department. The incumbent will be responsible for the following:

Protocol design and implementation
Manage study start up activities
Participation in site training
Site management and visits
Ensure integrity of clinical data
Ensure adherence to regulatory and company guidelines
Evaluation of clinical data
Assist with regulatory filings
Necessary administrative activities as part of the project team
Safety reporting
Assurance of adherence to regulatory guidelines and SOP’s

Other duties may be assigned as needed

Candidate Requirements:

Candidates should have a Bachelor’s degree (BA) in life sciences or equivalent from a four-year college or university.

Candidates must have 5+ years of pharmaceutical industry clinical/regulatory monitoring experience. Including multi-center clinical studies with appropriate knowledge of GCPs and regulations, or an equivalent combination of education and experience.

Candidate Experience:

You must have experience as primary management of at least one multi-center study and other phase 1-3 studies using CROs.

Candidates should have experience drafting or reviewing technical documents such as protocols, clinical study report, clinical sections of IND/NDAs, and safety reports.

Compensation

A compensation package will be designed to attract outstanding talent and will include a base salary, performance bonus, stock options, and an attractive benefits package.