Julian Granados Estrada

1.- Generate Granular and Accurate Grant Plans:

• Led cross-functional teams to ensure timely execution of clinical trials.
• Developed and maintained project timelines, ensuring adherence to regulatory requirements.
• Coordinated with external vendors to optimize resource allocation and project delivery.
• Implemented process improvements to enhance trial efficiency and data accuracy.

· Independently create detailed and precise Grant Plans for Investigator Fees using an

Industry Benchmarking Tool.

· Develop plans by trial, country, and other protocol

variables for all Novartis- sponsored studies.

2.-Translate Clinical Protocols:

· Convert the clinical protocol visit schedule of assessments into intelligent Grant Plans (Investigator Fees) and Fair Market Value (FMV) cost estimations.

· Ensure clinical operational and scientific requirements are accurately reflected.

· Collaborate closely with the clinical team for accurate "Grant Plan specifications" to improve estimates and reduce revisions.

3.-Provide Clinical Operational Feedback:

· Offer feedback to Clinical Trial Teams on the impact of study protocol procedures, visit design, and other aspects affecting the overall study forecast.

· Analyze by procedure, visit, patient, and country.

4.-Collaborate with Global Clinical Teams:

· Work with Global Clinical Teams using clinical expertise to identify and define clinical and operational issues within the study protocol design.

· Assess the impact of amendments and operational changes on cost constraints and inefficiencies and provide recommendations.

· Supported regulatory submission activities to FDA and EMA, ensuring alignment of operational and financial documentation with regulatory expectations.

5.-Engage with Countries and Regions:

· Ensure mutual understanding between Headquarters and Countries about Grant Plan outputs, country specifics, regulations, and overall workload at trial sites.

· Improve the quality and acceptance of Grant Plan reports.

6.-Identify Productivity Savings and Cost Avoidance:

· Identify early productivity savings and cost avoidance opportunities, such as frequency of assessments, indication level assessment, and country costs.

· Identify potential risks and opportunities based on existing portfolio information and benchmarks to enhance the robustness and accuracy of cost estimations.

7.-Act as a Subject Matter Expert:

Support clinical trial teams with the development and understanding of Grant Plan and FMV assessments.

· Provide training and guidance to team members to enhance their knowledge and skills.

8.-Support in FMV Activities:

· Provide support in FMV activities for the following in-scope areas:

· Local, Regional, Global supported Third Party Sponsored (TPS) Investigator Initiated Trials (IITs).

Novartis Sponsored

• 1.-Generate Granular and Accurate Grant Plans:
• · Independently create detailed and precise Grant Plans for Investigator Fees using an Industry Benchmarking Tool.
• · Develop plans by trial, country, and other protocol variables for all Novartis- sponsored studies.
• 2.-Translate Clinical Protocols:
• · Convert the clinical protocol visit schedule of assessments into intelligent Grant Plans (Investigator Fees) and Fair Market Value (FMV) cost estimations.
• · Ensure clinical operational and scientific requirements are accurately reflected.
• · Collaborate closely with the clinical team for accurate "Grant Plan specifications" to improve estimates and reduce revisions.
• 3.-Provide Clinical Operational Feedback:
• · Offer feedback to Clinical Trial Teams on the impact of study protocol procedures, visit design, and other aspects affecting the overall study forecast.
• · Analyze by procedure, visit, patient, and country.
• 4.-Collaborate with Global Clinical Teams:
• · Work with Global Clinical Teams using clinical expertise to identify and define clinical and operational issues within the study protocol design.
• · Assess the impact of amendments and operational changes on cost constraints and inefficiencies, and provide recommendations.
• 5.-Engage with Countries and Regions:
• · Ensure mutual understanding between Headquarters and Countries about Grant Plan
• · Improve the quality and acceptance of Grant Plan reports.
• 6.-Identify Productivity Savings and Cost Avoidance:
• · Identify early productivity savings and cost avoidance opportunities, such as frequency of assessments, indication level assessment, and country costs.
• · Identify potential risks and opportunities based on existing portfolio information and benchmarks to enhance the robustness and accuracy of cost estimations.
• 7.- Act as a Subject Matter Expert:
• · Support clinical trial teams with the development and understanding of Grant Plan and FMV assessments.
• · Provide training and guidance to team members to enhance their knowledge and skills.

• CRA responsibilities for two regional studies: Evaluating the quality and integrity of site practices – escalating quality issues as appropriate.
• Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
• Assesses site qualification potential: reviews study requirements; conducts pre-study visits and drafts pre-study evaluation reports.
• Worked well in a team setting, providing support and guidance.
• Passionate about learning and committed to continual improvement.
• Managed time efficiently in order to complete all tasks within deadlines.
• Assisted with day-to-day operations, working efficiently and productively with all team members.

• 1. To perform a qualitative and quantitative
• Analysis of the CTS required for the study
• Conduction.
• 2. To advice on the acquisition plan for all the CTS related to the study Conduction..
• 3. To assure that the applicable legal requirements for CTS availability at the country
• (i.e. Import Licenses) are timely obtained, as
• 4. To act as primary contact for the supplies,
• 5. To verify that the whole supply chain
• (reception, storage, distribution and final
• 6. To actively collaborate in the preparation and preparation and maintenance of local/regional procedures as required.
• 7. To deliver required training in their expertise area to involved team.
• 8. Work with CRAs, site, repository CRO,
• 9. Participate in document creation project forms.
• 10. Attend project team meetings to provide input about sampling logistics and timelines.
• 11. Adhere to Clinical Operations or project specific quality documents (e.g. SOPs, work practices, training guides), as applicable
• 12. Assists with the SIV´s of site as needed to address any compliance issues.
• 13. Assists with core lab and clinical research organization (CRO) management to meet with timelines.
• 14. Work closely and oversee CRO and local depot to assure the availability of the supplies in the investigational site.
• 15. Coordinate logistics with operations to assure both internal and external customer satisfaction.
• 16. Oversee CRO and local depot study close- out. Liaise with internal Functions to ensure drug destruction process is implemented.
• 17. Contact carrier representative to make arrangements and to issue shipping instructions and delivery of materials.
• 18. Document and escalate any customer service issues and/or shipping/receiving errors.
• 19. Ensure all Export Compliance regulations are strictly adhered to.
• 20. Prepare all required documents related to shipping such as Commercial Invoice, Shipper’s Letter of Instruction, packing slips and other required documents.
• 21. Perform other duties as assigned by the General Manager.
• 22. Interaction with courier companies, brokers and customs author

• Continuing education in [Subject]