Description
Primary Responsibilities:- Responsible for conducting clinical programs consistent with applicable regulations, guidelines, and policies. Ensures study adherence to ICH/GCP and SOPs
- Research, prepare, and revise the study protocol, Monitoring Plans, Informed Consent/Assent Forms, Case Report Forms, etc., in consultation with the cross-functional project team, investigators, data management, and biostatistics.
- Prepares clinical documents for IRB/EC submissions.
- Prepares training materials for investigators, site staff, and clinical staff. Conducts site initiation and monitoring activities as necessary.
- Develops project timelines. Develops and manages study budgets. Ensures appropriate resources and priorities are maintained for the various projects assigned to their area.
- Assists Data Management, as required, with review of clinical data/information and provides oversight of data correction as necessary.
- Manages activities performed by Contract Research Organizations or other vendors.
- Able to evaluate clinical data/information and write, review or revise clinical sections of annual, interim, and final reports, and clinical sections of regulatory submissions as necessary or requested.
- Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work, including negotiation of scope of work, budgets, performance management, and issue resolution.
- Assists the Senior Director and/or Quality group with SOPs and training requirements.
Skills and Experience:
- Bachelors Degree required; Life Sciences Preferred
- Driven to deliver results with the ability to establish rapport, earn trust, and effectively collaborate with others.
- Proven clinical development experience of the operational aspects of all stages of clinical studies, preferably working in a global environment and/or including monitoring, leading clinical subteams, working with vendors and CROs, managing drug supply, and planning operational activities to achieve database lock.
- Experienced in project management, including development of timelines, budgets and resource plans.
To find out more about Real please visit www.realstaffing.com