Associate Clinical Trial Manager
Charlene Dutchman at CK Clinical is recruiting for an Associate Clinical Trial Manager to join a leading, multi-speciality health care company, on a permanent basis.
As an Associate Clinical Trial Manager you will ensure that clinical strategies are translated into operational plans and executed in line with clinical development plans. In particular you will align operational execution activities with agreed upon project priorities, timings and quality specifications and adhere to all relevant regulations including GCP, ICH and PhRMA guidelines, Regulatory requirements, and SOPs and policies.
As an Associate Clinical Trial Manager you will be expected to assist the Global / Regional Study Managers in the operational execution of clinical studies and be responsible for performing tasks as assigned by the manager. This may include, but is not limited to; preparing, collecting, and tracking master study level documents and site non-regulatory documents; reviewing, updating, and testing clinical systems, and producing reports on clinical status, trends, and metrics. You will be involved in facilitating communication across departments and supporting the monitoring team and study sites with relevant study information, and supporting clinical operations.
Key Accountabilities/Responsibilities of an Associate Clinical Trial Manager will include the following:
- Ensuring all site related activities and files are completed per the SOPs.
- Acting as a key point of contact for study specific questions from both internal (eg, site monitors, clinical services specialist) and external (eg, site personnel, vendors) customers.
- Facilitating communication across departments and elevating site and study issues as appropriate.
- Reviewing clinical data through various sources in order to monitor overall clinical data quality and identify and resolve potential study or site issues as appropriate.
- Performing quality checks of all study plans (e.g., monitoring plan) and study reports.
- Review and code protocol deviations.
- Set-up, test, review, and update clinical systems (e.g., CTMS) and tracking tools.
- Being responsible for collecting and tracking study specific data and producing clinical status, trend, and metric reports to assist the manager in proactive study management and contingency planning.
- Being responsible for the logistical tasks associated with the preparation, collection, review and tracking of the master and site non-regulatory file documents.
- Ensuring the accuracy and completeness of all study files prior to final archival.
- Being responsible for completing all required training to execute responsibilities and maintain training records.
- Being responsible for reporting any potential GCP violations either internally or externally to the manager and participate in any corrective and preventative action plans as appropriate.
- Being responsible for reporting any safety concerns to the appropriate department including but not limited to Serious Adverse Events.
- Being responsible for documenting key communications from either internal or external sources in the study file.
As an Associate Clinical Trial Manager, you will have the following qualifications, skills and experience:
- B.A./B.Sc. preferably in science or health-related field.
- Previous experience of clinical study management.
- Oversight or mentoring of more junior study monitors (direct or indirect) preferred.
- Good understanding of the following: Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based),
- Knowledge of concepts of clinical research and drug development, and General therapeutic area education and training.
- Handle and prioritize multiple tasks simultaneously
- Work effectively in a team/matrix environment
- Understand technical, scientific and medical information
- Handle conflict management and resolution
- Understand clinical study budgets
- Plan, organise, project manage and analyse data, and
- Demonstrate full competency in Microsoft Office programs.
For more information or to apply for this Associate Clinical Trial Manager please contact Charlene Dutchman on 01246 45 77 33 or email firstname.lastname@example.org. Alternatively, please click on the link to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL33537 in all correspondence.