Asad Akhtar

About Asad Akhtar

A result oriented professional experience in clinical research since 2005.• Recruit, retain and develop a skilled, experienced and motivate “Project Planning & Support team”.• Developing appropriate orientation/induction program, ensure timely and accurate Access Granting, Access Review and Access Revocation for all CTMS systems (e.g. Electronic Documents Data Base, Clinical Information Management System, EDC systems-INFORM, RAVE, Data lab, Oracle, International Safety Information System etc.)• Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, communicating to the staff in an open, balanced and objective manner.• Manages the Global project team members (CRAs, CMAs, CTSs, other as appropriate), in Singapore United Kingdom and Malaysia, Germany and Australia and oversees Monitors study timelines, patient recruitment, retention and data cleaning to ensure successful outcomes, and the project deliverables are met. • Perform the role of co-Clinical Lead or Clinical Lead as/if required on allocated project, exercising• The responsibility is to perform all clinical monitoring / site management activities for assigned projects in accordance with SOPs. My assignments includes Feasibilities (onsite and telephonic), Site visits including Feasibilities, Initiation visit, Monitoring visits & SDV, Closure visit, Site Selection visits, Audits and Investigator Meetings • I was a part of many Clinical trials from Phase II to Phase as a CRA for the therapeutic areas like, Pulmonary Atrial Hypertension, COPD, Cardiology, Active Rheumatoid Arthritis, Dermatology and Surgery. In most of these trials I was actively involved starting from site feasibility to database lock. • Experience of regulatory inspection Systemic and Independent audits. • Able to travel (National/International) a minimum of 65% on average• Overseas Monitoring Experience in Singapore United Kingdom, Malaysia, and Germany.

Experience

1. Senior Clinical Research Associate

   Parexel

   Mar 2023 — Present · US

   Perform the role of co-Clinical Lead or Clinical Lead as/if required on allocated project, exercising ownership for Global project activities which are related to the monitoring function.•Assume the ability to meet the requirements of a CRA I and CRA II with a high degree of proficiency and autonomy. •Shows solid understanding of therapeutic indications and study hypothesis. •Act as an independent CRA Coordinator on complex or multiple Global projects.•Represent function in external client meetings and presentations such as investigator meetings /bid defenses professional meetings as required. •Function as mentor and role model for other CRA team members to ensure study specific training for CRAs. •Perform co-monitoring visits with less experienced CRAs or at problem sites as required. •When acting as a co-Clinical Lead or Clinical Lead, review reports generated by other CRAs assigned to the project in the region. Highlight common issues and address these with the team as a training need. •To review the time budgeting, incorporating revenue recognition, to ensure that any potential cost over-runs are identified and addressed at an early stage.• Perform ongoing on site data management/collection to ensure that issues relating to the quality of the data are communicated to the site personnel early and maintain close contact with Data Management. •Maintain project tracking system (Clinical Trial Management System, Patient Recruitment Plan, SPARC) on an ongoing basis to ensure that progress regarding the sites can be tracked. Provide status updates to the Project Manager, CL and client as required.•Attend staff meetings and training sessions as required to complete the worldwide training in a timely manner.•Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.

Education

• Rajiv Gandhi University of Health Sciences

  Bechlore of Pharma, Pharmacy

  1999 — 2004

Skills

• Immense Experience and Knowledge and Imbibed Qualities in Clinical Research
• Team Player with Outstanding Negotiation and Organizational Skills.
• Willingness to Work with Multiple Supervisors/Colleagues in a Matrix Environment
• Act as an Independent Cra Coordinator on Complex or Multiple Global Projects.
• Clinical Research Management
• Exercising Ownership for Global Project Activities Relate to Monitoring Function
• • Excellent Interpersonal, Site Management and Relationship Building
• • Sound Experience of Regulatory Inspection / Systemic and Independent Audits.
• Ich-Gcp Guidelines
• Able to Travel (National/International) a Minimum of 65% on Average
• Review Reports Generated by Other Cras Assigned to the Project Globally.