Department: Medical Research
Job Title: Clinical Trial Manager - Oncology
Description:
As a key member of the medical research team, you will participate in the gamut of activities involved in the preparation for and implementation of clinical trials. These activities include: (1) contributions to the development and preparation of clinical documents [e.g., protocols, informed consent, amendments, etc.], (2) clinical site interactions [including site monitoring, enrollment tracking, clinical trial material and clinical supply requests] in conjunction with the CRO, (3) interactions with the CRO at team meetings and independently to follow-up on observations, (4) interactions with other ARIAD departments including Regulatory, Quality Assurance, Bioanalytical and Discovery, (5) participation in development team meetings, (6) contribution to program plans, (7) review and comment on clinical trial data, and (8) clinical trial and regulatory document tracking.
This position provides an opportunity to contribute substantially to the successful implementation Oncology trials with the lead product candidates at ARIAD. In addition, there is an opportunity to build skills in the science of clinical research as well as oncology through day-to-day activities and close interactions with the medical research group, formal training and participation in oncology meetings where clinical trial data are presented. There is an opportunity for growing responsibility and activities commensurate with the individual's enthusiasm and eagerness to learn.
Responsibilities
The clinical trial manager is responsible for the development and management of assigned clinical trials, including:
- Preparation and review of protocols, amendments, consent forms, case report forms, and other trial related documents.
- Management of external vendors, including CROs and specialty laboratories.
- Review of site visit reports and safety documents.
- Co-monitoring activities at clinical study sites and laboratories to assure adherence to good clinical and laboratory practices, S.O.P.'s, protocols, and contractual specifications.
- Preparation and management of study budgets.
- Preparation of clinical portions of regulatory documents as required
- Participation in clinical trial listing reviews.
- Preparation and review of clinical study reports.
Additional responsibility will be to track administrative and regulatory documents pertaining to the investigative sites. The successful candidate also will interact closely with the CRO providing site monitoring and management services as well as the clinical sites participating in the clinical trials.
Technical Skills
Knowledge and understanding of the clinical trial process and GCP/ICH is mandatory. Proficiency with computer software such as Word, Powerpoint, Excel, and Microsoft Project is desired, however training will be provided as needed.
Job Requirements:
This position requires at least a B.S. in Chemistry, Biology or a health-care-related field. Job position and title will be commensurate with experience. A minimum of 2 years of clinical research experience required. The qualified candidate will possess proficient oral and written communication skills, and be detail-oriented with strong organizational abilities. Additional attributes include an ability to multi-task, be flexible, and to thrive in a fast-paced environment. Excellent interpersonal skills, with a demonstrated ability to work in a team environment as well as independently, are required. Must be able to travel (mostly domestic, 25 – 30%). This travel includes site visits as well as participation in major Oncology meetings where clinical data are presented.
