Associate Clinical Trials Manager
Charlene Dutchman at CK Clinical is recruiting for a number of Associate Clinical Trial Manager's to join a leading, multi- speciality health care company on a full time, temporary basis , for 12 months in the first instance.
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. 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:
- Ensure all site related activities and files are completed per the SOPs.
- Act 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.
- Facilitate communication across departments and elevate site and study issues as appropriate.
- Review clinical data through various sources in order to monitor overall clinical data quality and identify and resolve potential study or site issues as appropriate.
- Perform quality checks of all study plans (eg, monitoring plan) and study reports.
- Review and code protocol deviations.
- Set-up, test, review, and update clinical systems (eg, CTMS) and tracking tools.
- Be 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.
- Be responsible for the logistical tasks associated with the preparation, collection, review and tracking of the master and site non-regulatory file documents.
- Ensure the accuracy and completeness of all study files prior to final archival.
- Be responsible for completing all required training to execute responsibilities and maintain training records.
- Be 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.
- Be responsible for reporting any safety concerns to the appropriate department including but not limited to Serious Adverse Events.
- Be 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.
- Previous experience monitoring and co-monitoring is essential.
- Therapeutic experience with in GI, Urology or Ophthalmology is a desirable but not essential.
- Proven vendor Management experience essential.
- Global site experience (Ideally a minimum of 4 or 5 European countries outside of UK and Ireland)
- Work effectively in a team/matrix environment
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 CL34678 in all correspondence.