Job Description
The _**Senior Clinical Trials Management Associate**_ is a primarily an in-house sponsor position (although some travel is required) who will oversee multiple aspects of clinical trial conduct including study start-up, document generation and review, tracking of samples enrollment of study participants, and management of vendors.. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines. The position will report to a Senior Clinical Trials Manager of Clinical Operations.
Responsibilities include but, are not limited to:
- Prepares and/or reviews study-related or essential study start-up documents as they relate to the supported clinical trials as delegated by the study manager (e.g., Clinical protocols, Informed Consent Forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).
- Works with multiple contract research organizations to communicate detailed timelines and ensure that transferred obligations and performance expectations are met. Provides corrective instruction, as necessary, when performance expectations are not being met.
- Attends internal team and other meetings as required.
- Provides training, as necessary, at investigator meetings and other trial-specific meetings such as site initiation visits and monthly teleconferences.
- Creates and reviews site feasibility assessments required for study participation.
- Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations.
- Proactively identifies potential study issues/risks and recommends/implements solutions; ensures issues are escalated as appropriate to Senior Manager.
- Prepares metrics and updates to key deliverables for management.
- Assists in the resolution of clinical trial queries and data review for interim analysis, primary analysis and final database locks.
- Prepares site newsletters and other correspondence related to clinical trial conduct (eg, best practices and lessons learned, frequently asked questions) in collaboration with the study team
- Assists in resolution of routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol.
- May lead less complex studies and/or manage components of more complex studies as a member of the study team
- May participate in department initiatives or special projects, such as developing new tools or processes
- Ability to coach less experienced colleagues in solving problems
- Understands how decisions have an impact to the broader study goals
- Other duties as assigned.
Basic Qualifications
- BS/BA in nursing, science or health related field and 4 years of related experience – **OR -**
- MS/MA in nursing, science or health related field and 2 years of related experience
Preferred Qualifications
- Bachelor’s degree in nursing, science or health related field required with at least five years of related experience. At least three years of clinical trial experience with oncology, hematology or related therapeutic area experience considered a plus
- Multiple years of experience managing the work of external candidates
- Must be willing to travel at least 25% (possibly more)
- Ability to manage time demands, incomplete information or unexpected events
- Must display strong analytical and problem solving skills
- Attention to detail required
- Outstanding organizational skills with the ability to multi-task and prioritize
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Working knowledge of transplant patient care and apheresis collection a plus
