Farah Malik

I am a confident, organised, and self-motivated individual driven by my passion for science in clinical research. My experience comprises project management and remote site monitoring in Phase II–III Clinical Studies across a broad range of therapeutic areas, including technical support across medical and study-related departments. I aspire to progress in the Pharmaceutical industry with opportunities to learn new skills and achieve new challenges.

Therapeutic areas include: Vaccine studies (Norovirus and Influenza), Inflammation (Atopic Dermatitis), Neurology (Bipolar depression), Dermatology (psoriasis), cardiology (heart failure), neurology (Multiple sclerosis), Breast cancer, non-small cell lung cancer, melanoma, lymphoma and Hepatocellular Carcinoma, phases II & III within APAC, EMEA, USA.

Clinical Research Coordinator II at Velocity Clinical Research (2024-02 – Present)

• Coordinated day-to-day clinical trial activities across multiple studies, ensuring compliance with study protocols, ICH-GCP guidelines, and company SOPs.
• Conducted patient visits and supported participants throughout study participation, including training on study questionnaires and electronic diaries (e-diaries) to ensure protocol compliance and accurate data capture.
• Monitored, documented, and escalated patient safety information, ensuring timely reporting of adverse events (AEs) and serious adverse events (SAEs).
• Performed laboratory sample processing and maintained accurate documentation to support data quality and study timelines.
• Maintained clinical trial documentation, including Investigator Site Files (ISFs), study trackers, and regulatory documents, to support audit and inspection readiness.
• Maintained Clinical Conductor and tracked patient status and enrolment metrics.
• Supported patient recruitment and enrolment through participant pre-screening and identification of external consultants to support recruitment targets.
• Managed multiple study trackers, including Study Access, Patient, and Substantial Amendment trackers, to support effective study coordination across teams and stakeholders.
• Led archiving activities for closed studies, ensuring compliant document management and organised study close-out processes.
• Collaborated with investigators, sponsors, CRAs, and internal teams to support study delivery, patient retention, and achievement of study milestones.

Research Portfolio Officer at Barts Cancer Institute Centre for Experimental Cancer Medicine (2023-04 – 2023-07)

Contract role

• Responsible for obtaining permissions and local approvals with relevant departments.
• Liaising with investigators to ensure sufficient capacity and resources for new projects.
• Taking the lead in coordinating and tracking the timely completion of Feasibility and Expression of Interest for lung cancer studies.
• Coordinate set-up meetings and Site Initiation Visits (SIVs).
• Responsible for creating Investigator Site File (ISF) and for the set-up of trials on the EDGE Research Management System.
• Determine timelines for study to set-up.
• Communicate effectively with relevant stakeholders.
• Act as a key point of contact for the University with sponsor sites (Pharma, CRO & other universities).
• Ensure any queries and questions are dealt with effectively.
• Schedule and coordinate documentation for the portfolio review meetings.
• Collate data for annual reports, monthly reviews of accrual data etc.

Senior Clinical Trial Management Associate at Gilead (2022-05 – 2022-09)

• Involved in supporting the study team in site selection, study implementation and ongoing coordination of study sites, and country management.
• Performing feasibility assessments for all sites and investigators using ZS ranking data.
• Collection of Confidentiality Disclosure Agreements (CDAs) and working closely with the contracts team to arrange new master/ site CDAs.
• Attended Bid-Defense meetings and was involved in CRO selection.
• Involved in setting up and managing central labs and study vendors, including liaising with study management CRO to ensure timely initiation.
• Creation of key study documents; Critical data and process form, Feasibility Questionnaire, Study and Monitoring oversight plan, Protocol Deviation Plan, Clinical Sample Management Plan, ICF changes tracker, Patient Reminder card, Dr to Dr letter and ICF customization.
• Building the Feasibility Questionnaire into Survey Monkey.

Project Manager at IBMS Business Unit (2021-04 – 2022-05)

Contracted by Syneos Health

• Acted as the European Lead for two Oncology studies and coordinated and monitored the activities associated with study deliverables across all applicable internal functional departments and vendors.
• During study feasibility involved in reviewing Principal Investigator Questionnaires and recommending sites for Pre-study visits.
• Reviewing Pre-study visit reports and recommending sites that should be selected and qualify for the study.
• Vendor management
• Reviewing and approving invoices and study fund setups in Oracle and CTMS.
• Tracking study risks and issues in Planview. Highlighting key issues and risks to sponsor during Weekly progress meetings.
• Develops contingency planning and risk mitigation strategies to ensure meeting or exceeding study milestones.
• Creation and maintenance of metric reports, inclusive of data collection from multiple sources, for delivery to clients or senior management.
• Involved in drafting key study documents (Trial communication plan and Trial Management plan)
• Participates in representing the company to the client, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively.
• In collaboration with the Project Team, plan, coordinate, and present at internal and external Meetings for assigned countries/regions.
• Routinely reviewing the TMF to ensure quality, completeness, and inspection readiness.

Maternity Leave (2020-05 – 2021-03)

Project Manager I at Allergan (2018-08 – 2020-05)

Contracted by Syneos Health

• Responsible for ensuring the assigned clinical studies are run on time and are completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.
• Working with the OSL and CTM to ensure studies are run to budget. Responsible for creating finance trackers and providing site monthly accruals.
• Study Initiation Phase; working with the CTM/OSL in region-specific (EMEA, US and APAC) document development including the informed consent forms; regional investigator meetings/presentation of materials; the development of regional enrolment initiatives; and planning regional clinical study supplies.
• Collaborating with the CTM/OSL in regional financial management; database lock activities; regional study drug management; regional trial master file management; regional study enrolment management (e.g. contingency plan execution); ongoing review of protocol deviations; regional vendor management; and ensuring adverse event reporting.
• During the Close-Out Phase: supporting database lock activities; ensuring all regional documents are filed in the TMF appropriately; ensuring all close-out activities are completed; ensuring study documentation is properly archived when the study is considered completed.
• Liaising with vendors (Biotelemetry, Covance, MESM, and CROs) to provide information for the import /export licence requirement for study sites in each country.
• Working closely with vendors to follow up on contract and Regulatory and Ethics submission status for selected sites in countries.
• Vendor management for clinical study supplies. For example, Lab kits, Ophthalmology supplies, and ECG machines.
• Arranging Skype study training sessions using Event Builder.

Project Management Associate at Amgen (2018-01 – 2018-07)

Contracted by ICON/Docs

• Supporting the management and oversight of global clinical trials (European and US sites)
• Maintaining study-level storyboard for critical timeline oversight
• To coordinate and manage the preparation of clinical trial documentation and training materials (including clinical study meetings, protocol training, and newsletters)
• Facilitate the development of Investigational Product Information Manual and study specific Important Protocol Deviation list
• Managing processes for planning, procuring, and oversight of ancillary clinical supplies
• Vendor management (including set up, tracking, and issue resolution over the life of the study)
• Tracking and collation of study data and metrics utilizing multiple clinical systems (Data Management tool and eTMF tool)
• Preparing clinical study team meeting agendas and minutes, facilitating cross-functional meetings
• Managing global versioning and distribution of documents (e.g. informed consent forms) and Essential document management.

Clinical Monitoring Associate II at PAREXEL International (2015-08 – 2017-12)

• Act as PAREXEL's remote contact with assigned 40/50 UK clinical sites over 5 studies, use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites.
• Prepare and collect high quality site documents, such as essential regulatory documents for Site Regulatory Package (SRP) for review and approval
• Submit and follow up with site on Clinical Site Agreement (CSA) including budget, Anti-Bribery Law (ABL) Survey (if not available), and site specific Informed Consent Form (ICF).
• Collect site specific documents for Institutional Review Board (IRB), Ethics Committee (EC), and Regulatory Authority (RA) as required.
• Provide prepared EC package to PI for submission and follow up to secure approval where required.
• Support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
• Conduct general site contacts in accordance with the study specif

Biomedical Science (BSc) 2009-2012