Clinical Study Manager II
Posting ID: JP-002027284
This opportunity is with a company whose research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.
Study Management and Leadership
- Has primary accountability for operational study level time, cost and quality deliverables.
- Lead the development of the clinical study plan including critical path activities and inter-dependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent.
- Lead the creation of the cross functional Clinical Study Oversight Plan (CSOP) under the guidance of the study team leader and take a leadership role in ensuring study team adherence to the CSOP and manage the overall implementation and documentation of the CSOP including activities conducted by CROs and vendors
- Provide operational input into study protocol profiles, final protocols and amendment
- Lead document review & coordination for the protocol and amendments.
- Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.
- Lead the CRO and vendor selection process in collaboration with the study team and outsourcing procurement management.
- Lead the creation of the CRO scope of work in collaboration with Outsourcing Procurement Management.
CRO, 3rd Party Vendor Management and Oversight
- Responsible for the oversight, performance and management of CROs and 3rd party vendors to ensure compliance with Company's quality measures and adherence to scope of work within timelines and budget at a task level. Specifically track operational study timelines and monitor operational performance metrics through the life of the study; Identify issues and propose solutions.
- Responsible for ensuring that the Clinical CRO(s) provide timely input and generate documents in a timely manner and with quality (e.g. communication plan, site monitoring plan, etc) as per study plan.
- Responsible for overseeing CRO study start-up activities and coordinating with functional groups to ensure that essential site documents are collected, and sites are initiated per study plan. Oversee and track site initiation and enrollment activities at the country and site level and develop mitigation strategies in collaboration with the CRO.
- Coordinate with the CRO to prepare and execute meetings including Vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings and training. Note that vendor management is not limited to the CRO, but includes 3rd party vendors (e.g. translations, trial insurance, and central laboratory, etc).
- Conduct and/or oversee the CRO oversight monitoring visits (CROOM visits) as outlined in the CSOP.
Additional Skills & Qualifications:
- 5-8 years of study management experience
- Vendor/ CRO management
- Inspection Readiness
- Pre-Inspection Interviews
- A Bachelor's degree (preferred in Life Sciences) is acceptable
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Jean Chambers
Phone: (410) 579-3072