[Job Description]
The Evidence Generation Specialist will lead the operational planning, delivery, oversight and budget management of company sponsored studies and/or externally sponsored studies and/or EAP/GATM (Early Access Program/Global Access To Medicine) ensuring the compliance of the clinical research process with ICH-GCP practices, the study protocol, AZ (AstraZeneca) global and local clinical SOP’s, and the regulatory authorities and IRB (Institutional Review Board) regulations.
[Typical Accountabilities]
- Ensures timely submissions of proper application/documents to IRB/Regulatory Authority, close communication with the relevant stakeholders such as clinical research lead and local, regional/global study teams and overall responsibility for study commitments, for timely delivery of data to required quality as agreed.
- Has the overall responsibility for the assigned study commitments within the country and for timely delivery of data to required quality.
- Supports/coordinates SDC (Study Design Concept), protocol development and finalization.
- Performs CRO (Clinical Research Organisations) oversight to help ensure project delivery within time, cost and quality.
- Collaborates with CRO/ESP (External Service Provider) to ensure the study operational aspects are effectively undertaken and that they have clear remits for delivery.
- Leads on activities related to setting up studies (local and regional), selecting CROs, assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
- Team player to support stud performance at country level ensuring compliance with AZ procedural documents, ICH-GCP and local regulations.
- Ensures, as required, that feasibility assessment of potential studies is performed to the highest quality.
- Coordinates the site selection process by identifying potential sites/investigators, ensures performing initial site quality risk assessment, and conducting site feasibility visits to evaluate suitability and quality risks.
- Ensures timely submission of application/documents to IRB at start up and for the duration of the study.
- Ensures timely readiness of country level master ICF and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant AZ SOPs and local regulations.
- Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.
- Plans and coordinates applicable local drug activities (for applicable studies).
- Supports the sets up of VCV at study country level as well as local websites as required by local laws and regulations.
- Oversees and manages monitoring activities from site activation through to study closure at country and site level in accordance with the monitoring plans.
- Performs co-monitoring, accompanied site visits/training visits as applicable.
- Contributes to patient recruitment strategy including regular communication with participating investigators as necessary.
- Proactively shares identifies risks and facilitates resolution of complex study problems and issues to support the development, maintains and reviews of risk management plan on country study level proactively manages sites, stakeholders to ensure risks are timely identified, mitigated, and managed.
- Communicates and co-ordinates regularly with national co-ordinating investigator/national lead investigator on recruitment and other study matters, if applicable.
- Plans and leads national investigator meetings, in line with local codes, as required.
- Ensures relevant systems required are set-up, updated and access is organised at country level.
- Ensures accurate payments related to the study are performed according to local regulations and agreements.
- Participates in training and coaching new members of the medical team ensuring compliance with ICH-GCP and AZ procedural documents.
- Ensures completeness of essential documents are ready in a timeline manner to maintain the eTMF “Inspection Ready”.
- Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.
- Plans and leads activities associated with audits and regulatory inspections.
- Provides input to process development and improvement.
- Supports the review of ESR (Externally Sponsored Research) proposals and protocols to enable a consistent, high-quality approach to evaluation.
- Ensures all operational delivery aspects of ESR are achieved within agreed timelines and budgets, to expected levels of quality, and in line with the legal and compliance requirements, escalating issues around non-attainment of performance metrics as appropriate.
- Ensures operational quality and compliance with policies and procedures for ESRs globally.
- Creates and implements alternative action plans proactively to reach the targeted patient numbers; planning and taking the necessary precaution when required.
[Essential ]
- Bachelor’s degree in related discipline, preferably medical, pharmacy or biological science or equivalent by experience
- Extensive pharmaceutical industry/CRO experience
- Good knowledge of international guidelines ICH-GCP as well as relevant local regulations
- Scientific awareness and extensive knowledge of observational study guidelines and SOPs
- Ability to effectively work with CRO/external providers
- Excellent verbal and written communication skills
- Excellent ability to prioritize and handle multiple tasks
- Excellent attention to details
- Good negotiation skills
- Good ability to learn and to adapt to work with IT systems
[Desirable]
- Proven ability to lead and motivate cross-functional teams to deliver studies according to or ahead of time plan, budget and with required quality
- Good medical knowledge and ability to learn relevant AZ therapeutic areas
- Good knowledge of the drug development process
- Excellent understanding of the clinical study process including monitoring
- Very good understanding of the study drug handling process and the data management process
- Excellent project management skills
- Excellent team building and interpersonal skills
- Integrity and high ethical standards
- Proven competence in the patient safety, clinical and regulatory field
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