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Trials, Publication & ME Lead

Lieu Bangalore, Karnataka, Inde Job ID R-185356 Date de publication 02/12/2024

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation 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.

Responsibilities

• Plan and deliver all local, regional & global company sponsored studies and externally sponsored research related activities across various therapeutic areas.

• Lead and drive the process of coordinating study protocol, CRF, ICF and other associated document development by obtaining insights from relevant cross functional and external stakeholders

• Identify, Initiate, lead and manage External Service Provider (CRO & DM), exchange contracts and negotiate costs for EDC, DM, monitoring, central laboratory, translation service etc.

• Provide Strategic input on EDC and review data management deliverables (e.g. eCRF specification, Data Validation Specification, Data Management Plan)

• Work with Medical Leadership and key stakeholders to priorities the needs and resources required to deliver Trials and Evidence generation activities.

• Lead and manage cross functional team/internal stakeholders; Legal, Finance, Regulatory etc. to ensure all supporting activities are completed in time

• Plan and prepare study budget and get management approval.

• Interface with local and global project teams to deliver various milestones

• Lead the process of externally sponsored research related activities

• Review and approve site and local vendor invoices/payments

• Provide Strategic input Prepare Monitoring Plan, SDV and QC plan for the study.

•Provide strategic inputs to site selection and number of sites to be selected

•Meet investigators and key opinion leaders for trial projects.

•Oversees the delivery of Corrective and Preventive Actions to time and quality, and acts on identified through the Quality & Risk Management process and GCP.

•Quality Issues reported from Medical Evidence activities in appropriate reporting system (e.g., VQV)

•Interact, with relevant Quality and Compliance functions relevant to Medical Evidence deliveries.

•Continuous improvement activities in evidence generation/ GCP area.

Line Management:

•Attracts, develops, and retains top talent and actively works to promote team building and morale within the department

•Ensures employees are properly trained, and possess required skills and knowledge

•Provides direction, real-time situational mentoring, career development guidance, and coaching as appropriate

•Provides performance management, performance assessment and reward and recognition proposals for direct reports

Publications Responsibilities:

•Lead and drive the progress of publications and update medical leadership and flag issues

•Work with Therapeutic Lead/Medical team to develop and manage publication plan for all evidence generating activities.

•Identification and selection of appropriate vendor/ESP and regular co-ordination

•Compliance check- adherence to publication policy etc.

•To Lead and manage the progress and ensure timely delivery of project.

Medical Excellence Responsibilities:

Lead and guide the team to ensure successful implementation of Medical team capability building and Medical Excellence programmes, also to ensure monthly department meeting, SOCRATES sessions, Annual Medical & Regulatory Workshops.

Collaborating with Senior management team, HR and TA Leads for devising various initiatives etc.

Education, Qualifications, Skills and Experience

Essential

  • Minimum University degree and / or equivalent, preferred in biological science or healthcare-related field.

  • Adequate & relevant experience of CT, Regulatory Mandated Phase IV studies, RWE, People & vendor management experience

Desirable

  • Extensive knowledge of operational aspect of Observational studies, clinical trials, end to end delivery of project.
  • Experience in External Service Provider (Data Management and central Laboratory) management

Key personal capabilities and attitude

Key Functional Capabilities

Demonstrate AZ Values Consistently

  • Excellent Communication Skills

  • Good Planning and Organisational Skills

  • Excellent clinical operational knowledge and Project management.

  • We follow the science

  • We put patients first

  • We play to win

  • We do the right thing

  • We are entrepreneurial

Key Relationships to reach solutions

Internal (to AZ or team)

External (to AZ)

  • Medical Affairs Function

  • Regulatory Team

  • Procurement team

  • Legal and finance teams

  • Healthcare professionals/Investigators  

  • Service Providers

  • Other local and regional stakeholders

  • Regulatory Bodies

Office Working Requirements
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

  • Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
  • Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
  • If you’re curious to know more then please apply to this post and we will revert back to you.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn: https://www.linkedin.com/company/1603/

Inclusion & Diversity: https://careers.astrazeneca.com/inclusion-diversity

Career Site: https://careers.astrazeneca.com/



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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Une culture d'entreprise inspirante, des missions riches, des managers qui accompagnent et soutiennent. Des opportunités de rotation rapide au sein de l'entreprise. Ils accordent de l'importance à l'inclusion et à la diversité.