Job Description
Clinical Study Manager/Associate Director openings with growing bio-tech firm in Northern, NJ!
"Go-getter" candidates with positive attitude and motivation to see goals through! Looking for candidates who are seeking growth and company advancement!
Qualifications
- BA/BS; Life Science degree, MA/MS/PhD a plus
- 5-7 years of industry experience in oncology clinical trials (with at least 3 years) as a study lead working with third party CRO's and various external vendors/stakeholders
- Solid understanding of functional area responsibilities associated with clinical development process
- CRO Oversight/Management Experience
- 2 years in Oncology (or rare disease experience)
- Global/Europe Management Experience
Summary of Job Responsibilities
- As a key member of the Clinical Operations team, successful candidate will work closely with the Executive Director/Vice President of Clinical Operations and will be responsible for leading the activities in the preparation, implementation, and completion of various clinical trials in accordance with the Clinical Development Plan.
- This position also provides an opportunity to join a growing development organization and contribute substantially to how the company will operationalize oncology trials in the future, while expanding internationally. In addition, there is an opportunity to expand your knowledge in the scientific and research aspects in oncology across multiple areas working on several assets, through day-to-day activities and close interactions with the Research and Discovery teams
Major Responsibilities
- Responsible for all operational aspects of clinical trial oversight including the delivery of studies on time and within budget and in compliance with GCP's, SOPs and standards
- Develop and ensure timely execution of operational study plan
- Responsible for selection and management of vendors, (CRO, Central Lab, specialty vendors, drug supply)
- Execute study start-up, timeline planning and management and financial management of clinical trials including vendor oversight
- Interface with the CRO regarding status of project activities and deliverables (including but not limited to site identification and selection, pre-trial activities, enrollment, management/conduct, database lock, post-study activities)
- Experience with data collection processes, data review and comfort with using technology including analytics toolsBuild strong relationship management between clinical sites, vendors, and internal team
- Proactive identification and communication to project leaders on project risks and contingency planning.
- Responsible for managing within approved trial budget(s)
- Review and prepare various clinical study related materials, including, but not limited to: model informed consent forms, study protocol and amendments, and Investigator Brochure.
- Maintain and ensure the quality and completeness of study master files across programs in compliance with GCP
- Preparation and oversight of study audits/inspections both internal and external
- Represent clinical operations in cross-functional initiatives - work closely with clinical development, discovery, translational and pre-clinical research colleagues.
- Must work independently, managing interactions with and between clinical monitors, biostatistics, medical writing, safety and other key stakeholders
About Aerotek:
Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.
