Location: Malvern, PA
Reports to: Director, Clinical Operations Infectious Disease & Immunology
The Clinical Research Manager drives and oversees the operational execution of clinical studies. This individual is responsible for the delivery of clinical studies according to agreed cost and timelines while ensuring patient safety and data integrity and quality.
Duties and Responsibilities
- Develops and directs clinical trials and operational activities and manages their execution to ensure completion according to project timelines and budget.
- Leads the study execution team ensuring that studies are conducted in adherence to study protocols, applicable SOPs, ICH/GCP guidelines and government regulations.
- Reviews and contributes to development of protocols, amendments, case report forms and clinical research reports. Develops informed consents and may contribute to development of annual reports and investigational brochures.
- Drives the identification, assessment, and qualification of clinical research sites. Ensures training of all investigational sites including planning of Investigator Meetings and development of site training materials.
- Develops study operational documents which may include timelines, enrollment projections, and study plans. Tracks performance relative to timelines and projections and ensures compliance with study plans.
- Works collaboratively with internal CRAs to ensure oversight of site initiation, interim monitoring, and site closure activities. Ensures the TMF is developed, maintained, reconciled, and archived.
- Assists in the identification and selection of CROs and clinical vendors. May manage the RFI and RFP process.
- Manages clinical vendors including CROs tracking of deliverables to ensure they are within timeline and budget.
- Provides study status updates to senior management and escalates study risks, as applicable.
- Works collaboratively with colleagues in Quality Assurance to develop and administer a study audit plan.
- Works collaboratively with colleagues in Finance to forecast, phase and manage study budgets.
- Ensures timely delivery of data for external safety board reviews as applicable.
- Proactively identifies risks, developing and implementing mitigation plans as applicable.
- May assist in developing policies and procedures (SOPs).
- Additional tasks and projects as requested.
- BA/BS degree, in life sciences.
- 5+ years of progressive clinical research experience in the biotechnology/pharmaceutical industry with 2+ years of experience as a Clinical Research Manager.
- Must have CRO/vendor management experience.
- Experience in Infectious Disease and Immunology and/or advanced therapy studies in Phases 1-3 highly desired.
- Strong knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical studies.
- Demonstrated attention to detail and outstanding organization skills.
- Self-motivated with a commitment to high quality, on-time deliverables.
- Excellent communication and collaboration skills with a team-oriented approach.
- Experience with eTMF, CTMS and EDC.
- Demonstrated ability to identify and resolve issues and effectively manage timelines.
This position operates in an office setting and may include 20% of travel to visit sites, vendors or CROs. Job may require incumbent to be available outside of normal hours to handle priority business needs.
This is a largely sedentary role.
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