Medical Evidence Generation

3 days ago

Riyadh, Saudi Arabia AstraZeneca Full time

**JOB TITLE**

**Medical Evidence Generation & Innovation Manager**

**Riyadh, KSA**

**ABOUT ASTRAZENECA**

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

**ROLE SUMMARY**
- Assigned Studies oversight of deliverables at country level to deliver committed components of the aligned clinical study according to agreed resources, budget, and timelines.
- Ensuring the compliance of the clinical research process with ICH-GCP practices, the study protocol, AZ Global and Local Clinical SOP’s, and the regulatory authorities and ECs Regulations; being knowledgeable about these procedures and keeping abreast of any changes and revision, participating in system/process improvement projects within local task groups consisting of employees from different units
- Perform site monitoring as needed to support capacity model and to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
- Preparation and conducting of Investigator Meetings, manage the process of creation, approval all essential documents developed or local customized ICF, Patients Material, responsible for distribution within the team of final approved version of all essential documents (Protocol, ICF, etc.).
- Creating and implementing alternative action plans proactively in order to reach the targeted patient numbers; monitoring the patience admission processes in coordination with the researchers; planning and taking the necessary precaution when required

**What you’ll do**
- Has the overall responsibility for the assigned study commitments within the country and for timely delivery of data to required quality.
- Lead on activities related to setting up studies (local and regional), selecting CROs, assist 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, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
- Ensures timely readiness of country level Master Informed Consent Form (MICF) 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)
- Support the sets up of CTMS at study country level as well as local websites as required by local laws and regulations.
- Oversees, manages, and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
- Complete monitoring visit reports (as required and following AZ SOPs)
- Performs co-monitoring, Accompanied Site Visits/training visits as applicable.
- Organises regular Local Study Team meetings on an agenda driven basis.
- Actively works towards achieving good personal relationships with all Study Team members, sites’ staff
- Reports study progress/update to the Evidence Generation & Innovation Head
- Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
- Proactively share 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 Evidence 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

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