Clinical Research Manager - Oncology
ProClinical is currently recruiting for a Clinical Research Manager - Oncology position on behalf of a top 10 global pharmaceutical company. This organization develops innovative products across multiple therapy areas including cardiovascular, oncology, and respiratory, and employs 100,000 staff globally. Based in the company's office in Pennsylvania, this position offers an exciting opportunity to work with an internationally renowned company and bolster a career in the Scientific field.
- Accountable for operationalizing Investigator Sponsored Studies (ISS's) studies within country and overall project management of study activities.
- Ensures development and maintenance of Area's of Interest, program plan and forecast, including detailed budgets, resource estimates, drug supply estimates, milestones, timelines, quality, and risk planning.
- Liaises with the ISS Oncology Coordinator for ISS proposal submissions.
- Collaborates with in-country study staff to communication with Sponsor Investigators. Communicates progress & escalates issues to the Operations and Science Leader (OSL) and other functions.
- Develops/manages the development of key study documents, plans & manuals (e.g., Protocol guidance information, IB, safety management plans, study reference manual, etc.).
- Coordinates review of ISS final protocol and informed consent form, clinical study agreement (CSA), third party agreements & payments.
- Manage endorsed studies in ISS management system including status and enrolment updates.
- Ensures necessary drug supplies are available at sites and manages local supply inventory .
- Responsible for collaborating with the ISS Sponsored to collect and verify al required. documentation (i.e. regulatory documents, this review) prior to the activation of any ISS.
- Participate in ISS review committee, act as ISS Committee project manager.
- Budget responsibilities:
- Develop ISS program level budget forecasts
- Review individual ISS budgets, ensure compliance to FMV for final budget, and that budget is within forecast.
- Estimate, track and deliver against the local clinical budget for assigned studies within scope of GSM responsibilities
- Participate as required in budget/contract negotiations with clinical investigator sites in collaboration with legal and central contracting group
- Ensure timely payments per contract
Skills and Requirements:
- BS/BA degree in a health-related science.
- A minimum of 5 years clinical/research experience.
- Demonstrated high level of understanding of clinical research and clinical trial management, and the associated regulatory, process and quality requirements.
- Demonstrated strong knowledge and experience in project management and matrix team interactions.
- Demonstrated operational expertise in risk management and contingency planning, understanding of local regulations, GCP/ICH-guidelines and application of company SOPs/guidelines.
- Availability and willingness to travel for project related activities as required (e.g., Investigator Meeting attendance, etc.).
- Areas of expertise includes Oncology.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Sarah Beshara at +267-477-3355 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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