Clinical Research Manager
Resume:
A. Mohammed Asif
********@*****.**.**
CAREER OBJECTIVE:
A well-tailored passionate individual having very good knowledge in Clinical Research looking for a challenging assignment and responsibility, with an opportunity for growth and career advancement as successful achievements. To succeed in an environment of growth and excellence and earn a job which provides me job satisfaction and self-development and help me achieve personal as well as organization goals.
SUMMARY:
Detail oriented clinical research specialist, offering over 9 years’ experience in clinical research, project management, site management and clinical trial data review in the pharmaceutical industry. Extensive knowledge of ICH-GCP and regulatory requirements while conducting clinical trials involving human subjects. Outstanding track record of successfully managing all clinical trial activities, including clinical site selection, studying initiation and close-out visits, training for on-site personnel and trial monitoring. Skilled in studying and implementing protocols, investigator manuals, site specific instruction manuals and case report forms. Expert in performing qualification, initiation, interim monitoring and close-out visits at clinical study sites to collect data, verify source data and review regulatory documents/files. Overseeing drug accountability at investigator sites as well as assisting in managing both clinical and non-clinical supplies.
KEY SKILLS:
ICH-GCP, SOPs and Regulatory Guidelines
Clinical Trial Monitoring
Site Management
Training Investigators
Drug Accountability
Task Prioritization
Clinical Site Selection
Clinical Reports
Staff Performance Monitoring
Quality Assurance and Control
Site Audit Training
Budget and Contract Negotiation
Industry Best Practices
WORK EXPERIENCE:
Current Position: “Senior Clinical Research Associate” at PRA Health Sciences working as “Central Clinical Research Associate-cCRA” for Novartis Healthcare Pvt Ltd, India since June 2014 to till date.
Job Responsibilities
Early adopter of Adaptive monitoring (risk based approach)
Perform ongoing central remote monitoring of patient data using available online data sources (eCRF, IRT, central lab, J-Review, Spot fire etc.) to ensure consistency and correctness of the data
Communicate any observations; deviations to protocol, safety alerts, quality issues, entry patterns, risk factors etc. that may affect the planned conduct of the trial to the clinical team and local ICRO organization / directly to site for timely follow-up actions and issue resolution.
Perform data query and resolution process
Study management systems update with e.g. key trial country and site event dates and enrollment figures.
Writing Monitoring Plan, eCRF design & review, and other documents and systems as applicable, ensuring accurate format for central monitoring.
Acts as a close partner with CRAs, CSMs and Global Trial Lead. A team member of the clinical trial team (CTT)
Interact with DM / CAF/ programming group and/or other line functions to ensure that efficient tracking and data reports are generated as required with flags and alerts for relevant deviations.
As applicable support Group Head - Central Continuous Remote Monitoring for ongoing medical/scientific review, and ongoing clarification of all remote queries to ensure smooth clinical database locks.
Adhering with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner.
Knowledge of applicable SOPs, guidelines and study procedures.
Assist with protocol and CRF review.
Developing informed consent forms.
Conducting study feasibility and site selection activities.
Assisting with the development of study manuals, annotated CRFs, monitoring conventions, tracking forms, site study tools, and other study materials.
Developing and implementing innovative approaches for and participating in site recruitment, selection and initiation activities.
Assisting with investigator meeting activities including organization, preparation and attendance.
Conducting site management activities, including but not limited to site qualification visits, site initiation visits, site training, site interim monitoring visits, and site close out visits.
Performing co-monitoring visits and performance assessment visits, when properly trained and delegated by Clinical Research Manager
Ensuring the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.
Writing study visit reports and follow up letters within the timeline established by applicable SOPs and guidelines.
Coordinate timely shipment of clinical supplies and study drug to sites.
Ensure proper storage, dispensation and accountability of clinical supplies and study drug.
Follow up of drug safety issues and safety reports in timely manner, if applicable.
Communicate site study issues, concerns, and progress Project Manager, Clinical Research Manager accordingly.
Development and implementation of corrective actions when appropriate.
Mentor for CRA I and/or CRA II, when assigned.
Conducting on the job training and formal training to other CRAs and Clinical Trials Assistants.
Collaborate with Clinical Research Manager/ study teams to resolve site issues.
Review study visit reports, follow-up letters and site communication generated by other CRAs for timeliness, quality, consistency, and appropriate documentation and resolution of issues, with support from Clinical Team Lead or Clinical Research Manager as needed.
Participate in routine study progress meetings, face to face or via teleconference
Previous Position 1: “Clinical Research Associate & Clinical Trial Manager”, in King Saud University, Riyadh, KSA since Oct 2011 to Sep 2013.
Job Responsibilities
Working as a Clinical Trial Manager & Sr.Clinical Research Associate
Designing CRF, Writing Protocols, Preparing workflows, Monitoring Plans, Study Tracker etc….
Experienced in submitting required study documents to regulatory authority SFDA as well as IRB and follow up to get the approval for the study
Training Junior CRA’s and perform assessment on them
Monitor each study to compliance with GCP, Study protocol and regulatory requirements.
Management, Supervision and Training of Research Staff
Coordination of all administration including purchasing and human resources
Preparation and Updating SOPs
Ensuring adherence to SOPs and Protocols
Liaising with investigators to assist with planning and set up of studies
Training to coordinators in protocol and study related activities.
Verifying for accurate, completeness of study file of each projects
Monitoring the progress of each project and produce monthly report
Overview all clinical trial and basic science research activities
Scheduling weekly meeting with staff to overview the stages of each project.
Conducting assessment of each individual staff and report to Director.
Previous Position 2: “CLINICAL RESEARCH ASSOCIATE II”, in CliniRx Research, Chennai from Nov 2010 – Oct 2011.
Previous Position 3: “CLINICAL RESEARCH ASSOCIATE II”, in Synchron Research Pvt Ltd, Ahmedabad from May 2009 to Nov 2010.
Job Responsibilities of
2 & 3
Identification of Potential Investigator for the study
Responsible for the conduct of Pre-study visit, Site Initiation, Monitoring and Closeout activities and preparation of reports for activities conducted in accordance with SOPs and SMMP
Responsible for training of team at site for startup activities & site Initiation
Training of Study Coordinator Internally
Will Perform 100% Source Document verification (SDV) per Monitoring Plan, Will verify that source documents and other records are accurate, complete, kept up-to date and maintained according to SOPs. Discrepancies identified on SDV should be discussed with the investigator(s) and corrected and documented appropriately.
Previous Position 4: SENIOR CLINICAL RESEARCH COORDINATOR at Apollo Hospital Education and Research Foundation under Apollo Hospitals Enterprises, Pvt. Ltd. from Oct 2006 to Apr 2009
Job Responsibilities
Reviewed criteria for inclusion and exclusion
Maintenance of documents in the site file
Reporting of serious adverse events
Scheduling patient consultations and Follow-Up
Filling Up Case Report Form/eCRF’s
Coordination With Central Lab and Study Team
Monitoring with in the Hospital Group
Training provided to study coordinators
Maintenance of all Study related tracking log – Screening log, EC Submission log, Drug Accountability, Fax log, Courier log, etc.
Previous Position 5: “CLINICAL COORDINATOR” at Baxter Healthcare Pvt Ltd., Chennai. from Sep 2005-Sep 2006.
Job Responsibilities
Coordinating between Nephrologists and patient who are all in peritoneal Dialysis (RRT).
Assisting and recruit the patient as per Doctor Discretion to come under the peritoneal dialysis Treatment.
Counsel and train the patient to perform exchange procedure by themselves.
Assess the patient well-being by routine patient home visit
Resolve the Technical problems as in case of Emergency requirement
To achieve the patient recruitment, patient survival and sales target for every month.
Organize many Kidney diseases awareness camp for ESRD patients.
CLINICAL TRIALS PROJECT EXPERIENCE:
A Phase IIIb Randomized, Double blind study in DME & CNV
A Phase III Randomized, Double blind study in Chronic Plague Psoriasis
A Phase III Randomized, Double blind study in Rheumatoid Arthritis
A Phase II Randomized, Open Label, in Fatty Liver Disease patients
A Phase IIIb Randomized, interventional study in Hepatitis (HCV) patients
A Phase II Interventional study in Hepato carcinoma
A Phase IIIb study in Schizophrenia patients
A Phase II study in Advanced Solid Tumors.
A Phase II study in Ulcerative Colitis patients
A phase IV study in chronic Hepatitis.
A phase III study in SLE patients with History of Renal disease.
A phase III study in Moderate to Severe COPD patients.
A Phase III study in Renal Transplantation.
A Phase II Double blind Safety and Efficacy of Investigational drug in Type II Diabetes mellitus.
TRAINING EXPERIENCE:
Attended advance Monitoring Skills conducted by ISCR, Mumbai on November 2010.
Participated in Study Protocol Designing Program Conducted by PFIZER Pharmaceutical Company.
Participated in Investigator Meeting conducted by Bristol Myers Squibb and Schering Plough.
Completing 6 weeks course in Dialytic techniques at Indraprastha Apollo Hospitals, Delhi
Participated in Spirometry workshop at Chest Research Foundation, Pune.
Trained in Master-scope CT and AM2+ (eDiary) as well as ECG course, eRT Academy
Successfully Completed ICH-GCP web based training program conducted by Bristol Myers Squibb & AHERF.
EDUCATIONAL QUALIFICATION:
Qualification
Degree / Specialization
Class
University / Institution
Clinical Research Associate
Clinical Trial Monitoring and Research Site Coordination
Ist Class
Kriger Research Center, Canada
Master of Science
Biochemistry
Ist Class
Madras University, INDIA
Bachelor of Science
Biochemistry
Ist Class
Madras University, INDIA
PERSONAL DETAILS:
FATHER’S NAME : Late. Mr. Abdul Gafoor
BATE OF BIRTH : 21 Dec 1979
NATIONALITY : Indian
MARITAL STATUS : Married & 2 children.
LANGUAGES KNOWN : Arabic, English, Hindi, & Tamil
MOBILE NO : 0091-888-***-****
DECLARATION:
I hereby declare that the information furnished above is true and is to the best of my knowledge and belief.
[A. MOHAMMED ASIF]
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