Assistant Manager - Medical Data Review (Clinical Monitoring- Centralized)
Quintiles Research Organization
Total years of experience :17 years, 3 Months
Management Roles:
• Played a Leadership Roles in startup study activates and Innovative & Active planning’s.
• Successfully executed and conducted the assigned studies.
• Understanding the Risk Management issues and well managed the situations during the study conduct.
• Managed the team members with limited to the particular study.
• Guided the new team members during trainings and successfully placed into the studies.
• Mentored more than 10 plus members & Done Peer review, Quality Review for members worked under my study and to the members worked in other studies.
• Involved in the role of SMEs (Subject Matter Expert) and conducted trainings based on the respective topics.
Responsibilities:
• Reviewing the structured clinical patient data’s without direct access to medical charts to determine adherence to protocol and overall completeness of the supplied patient information for next level of review and reporting.
• Identifying any anomalies in patient reported data that require further investigation with the clinical site to determine overall accuracy.
• Reviewing investigation product dosing records, all reported Adverse Events (AEs), Concomitant Medications to ensure no medication is disallowed per protocol, supports
• Ensuring the proper end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending participation in the clinical trial.
• Reviewing all lab results to ensure completeness of information supplied, adherence to protocol schedule of events and determine if reported lab values represent a potential safety condition not reported in the AE information for the patient.
• Reviewing all patient reported medical history to verify completeness of reported information &determine overall readiness of the patient information for next level review.
Studies Information:
Therapeutic Area Indication
Bone Osteoporosis -2 Studies
Oncology Metastatic Breast Cancer - 1 Study
Oncology Multiple Myeloma - 1 Study
Cardio-Renal Dyslipidemia - 2 Studies
Neuro Science Chronic Migraine - 4 Studies
• Over all in charge of day to day activities of the assigned clinical trials.
• Assisting the investigators in conducting clinical trials and research according to Good Clinical Practice guidelines and meet international standards.
• Developing and managing a team of recruiters for clinical trials and research.
• Determination of patient eligibility.
• Documentation of all project related activities.
• Planning the trial logistics by liaising with hospital departments for administration and ancillary support.
• Adhering to the policies, practices and regulations established by the Investigational Medicine Unit, Research Office and various regulatory authorities pertaining to Trials.
• Developing the recruitment strategies for clinical trials.
• Preparing and maintaining the reports
• Having good listening and communication skills. Knowledge of different languages and dialects is advantageous.
• Capable of strong interpersonal skills, good supervisory and management skills, as well as leadership qualities.
• Reporting the serious adverse events of the site within the time frame to the sponsor as well as the ethics in their prescribed format.
• Good knowledge in entering the data and the safety information of the patients in the eCRF.
• Good Knowledge about ICH-GCP guidelines.
• Ensure compliance of SOPs.
• Submitting safety reports database.
• Reviewing, summarizing & submitting safety reports of the patients from different sites to the Ethics committee.
• Perform activities/tasks as communicated by the principal investigators.
• Performing study drug accountability.
Oncology Clinical Pharmacist Responsibilities:
• Dispensing, Preparation & mixing of Chemotherapy drugs as per the prescription.
• Chemotherapy orders must be viewed clearly for preparation of Medication Label, Check list (name of the drug, dosage, diluents, route and duration of administration, premedication) with the doctor’s signature and date.
• BSA (Body Surface Area) to be calculated.
• ANC (Absolute Neutrophil Count) must be verified and documented.
• The patient’s lab reports to be reviewed, documented and approved by the physician.
Accurately dispensing drugs to patients according to a doctor’s prescription.
Checking prescriptions for errors & making sure they are appropriate for patients.
Measuring, packaging, labeling and recording medications issued to patients.
Instructing patients on how to use medications, possible side effects and storage.
Contacting and working closely with other healthcare professionals.
Ensuring the accuracy of all prescriptions, products and services supplied.