Clinical Study Manager
Northbrook, IL 60062
Responsible for internal Clinical Study management between CRO and internal study team throughout the study process. Processes and reviews various study and study related governance documents. Leads the internal study team via scheduling and conducting weekly meetings to include minutes. Attends weekly CRO call and relays items needing attention of study team via weekly internal study meetings. Responsible for operational support of the clinical studies to include management of study budget and vendor contracts. Scope may include 1-2 different product programs representing up to 3-4 different Phase I and Phase II clinical trials. This role will collaborate with 1-2 medical directors, study team, and CRO team.
Oversees CRO as contracted for the following services:
• Site Monitoring: Participates in pre-study/initiation meetings with site investigators and study coordinators to ensure complete understanding of the clinical study objectives and data requirements. Working under close supervision of a Clinical Study Manager, monitors clinical sites to ensure adherence to protocol (including appropriate patient selection) and safety requirements. Ensures accuracy and completeness of the data in CRFs and resolution of data queries. Ensures electronic CRF completion and study data entry into internal tracking systems. Reports trends and observations noted at sites to study team. Ensures prompt processing of drug requests. Reviews pharmacy drug accountability records; reviews and ensures updates to essential document/regulatory binders. Ensures that Investigators have received and processed SAE information as required. Identifies protocol modifications as needed. Provides necessary study updates to Clinical Management on a regular basis. Performs study closeout visit activities ensuring that required documents are in order.
• Site Management: Establishes and maintains working relationship with study coordinators and investigators at assigned study sites. Ensures the delivery of all supplies and equipment to assigned study sites. Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives. Perform SIVs, IMVs and Close out Visits.
• Site Evaluation: Assists in identifying study sites, developing feasibility questionnaires (with oversight from CSM or designee) and training documents for CRO personnel to perform pre-study visits. Perform pre-study visits; reviewing study-related information with potential investigators (study synopsis, study logistics). Makes recommendations to the CSM on site selection.
• Document Preparation, Processing and Review: Evaluates and reviews clinical data. Assists in developing and reviewing CRFs, creating site administrative binders and developing monitoring tools. Reviews data listings for accuracy and completeness. Demonstrates an understanding of assigned protocols including therapeutic area, study drug and Investigator Brochure. May draft materials including informed consent documents, protocols, patient instruction guides and case report forms.
• Planning: Assists the Clinical team in the preparation and execution of study plans (e.g., monitoring plan, communication plan, etc.); supports the internal set-up of trial management systems in support of the clinical study. Creates and maintains various study trackers. eTMF management, collection.
• BA/BS (natural science major strongly preferred) with typically at least 2 years of relevant experience (or 1+ years experience with Masters or Ph.D. degree).
• Oncology study experience (excluding Phase 4 studies) is a must.
• Must have knowledge in reference to good clinical practices regulations and standard operating procedures.
• Working knowledge of ICH and GCP guidelines is required.
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
• Knowledge of clinical study operations and 2-3 years previous experience as a clinical study manager.
- Experience in the healthcare field.
- BA/BS in life sciences
- 5+ years clinical research experience