Parexel Work Values

Daily Duties at Parexel:

Facilitating the project planning and decision taking process, to communicate with various internal and external functions. Interact with study participants as directed/required by the protocol and/or study team, executing day-to-day data analysis of the operational study status (planned versus current) and reporting activities. Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities. Responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries. Coordination and management of clinical trials, including communication with Sponsors and regulatory authorities and vendors Site management activities: I manage study initiation, study closeouts, monitoring and documentation verification, data collection in accordance with ICH GCP guidelines, to monitor clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), track required information, editing Protocols and reports per client requirements, generate and maintain study checklists, assists in development of various forms, coordinate the approval process of critical documents such as protocol, to ensure budget information is current and timelines are met, follow up with adverse event reports, track, ensure that the site complies with the serious adverse event reporting requirements as defined by both the client and regulatory authorities within the specified time periods. Examine and draw conclusions from clinical data: I have experience in patient imaging techniques used across multiple modalities including CT, MRI, Bone scan, Brain scan, Venography, DXA scans, etc, read patient imaging, draw preliminary measurements on the scans, masking subject confidential information, present the findings to independent and medical reviewers, review CRF findings and submit CRF to the site and concern study personals. Site and Client Relationship: updating and deliver trainings to the investigator/ clinicians to understand their unmet needs, manage workflow issues, study specific issues through meetings/WebEx/T-con, work closely with the Clients, Clinical Trial Manager (CTM), project leads, Clinical Project Team to support various aspects of a Clinical Trials, regularly obtain all necessary information from CROs, CTMs, CRAs and to ensure that trial specific information is current and complete; Interact with client, sites, CRO`s and study team members on day to day basis via email and phone to resolve site and client issues/complains/queries/concerns in timely manner, follow up with sites for get queries resolutions, update tracking system and documentation.

What they like about Parexel:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

Tags

Clinical Trial, SAE, Site query resolution, safety reporting, Formulating source documents, ICF, informed consent, CRF, IRB submissions, study start up, study closeout, adverse events reporting, Good Clinical Practice (GCP), Standard Operating Procedures (SOP), ICH GCP guidelines, Interact with client, sites, CRO`s, update tracking system, Site payments, Budget, CT, MRI, Bone scan, X ray

Skills

Project management skills, Ability to prioritize work, Leadership skills, To get things done well within time and in agreed budget, Can work under pressure

These are some of the questions we asked our climbers about their experiences with Parexel: