Ready to shape how complex oncology trials are delivered in practice?

Accountabilities

• Hold overall accountability for meeting country-level study commitments, ensuring timely delivery of high-quality data.
• Lead Local Study Teams for assigned studies, including CRAs, CSAs and other contributors, promoting collaboration, clarity of roles and strong performance.
• Drive optimal performance and compliance of Local Study Teams with AstraZeneca Procedural Documents, ICH-GCP requirements and local regulations.
• Oversee high-quality clinical and operational feasibility assessments for potential studies, providing robust input into study selection and design.
• Coordinate and manage the site selection process, including identification of potential sites and investigators, initial site quality risk assessments and, where needed, Site Qualification Visits to assess suitability and quality risk.
• Ensure timely submission of applications and documentation to Ethics Committees/IRBs and, in partnership with Regulatory Affairs, support delivery of submissions to Regulatory Authorities in line with local requirements.
• Prepare accurate country-level financial agreements and maintain current study budgets within the clinical financial system, working closely with Director SMM or Director Country Head and Clinical Finance as appropriate.
• Ensure effective set-up and ongoing management of studies within CTMS, eTMF, study finance systems and any other tools or local platforms required by country-specific laws and processes.
• Oversee, manage and coordinate all monitoring activities from site activation to closure according to Monitoring Plans, reviewing monitoring visit reports and providing guidance and support to monitors.
• Conduct co-monitoring visits, accompanied site visits and training visits with study CRAs to drive quality, consistency and development.
• Proactively identify risks, facilitate rapid resolution of complex study issues and escalate when necessary.
• Organize and lead regular, agenda-driven Local Study Team meetings that enable transparent communication, issue resolution and aligned decision-making.
• Build and maintain strong working relationships with Local Study Team members, site staff and global stakeholders to support smooth study execution.
• Report study progress, milestones, risks and mitigation plans to the Global Study Associate Director, Global Study Team and SMM/Study Operations Lead as applicable.
• Contribute to patient recruitment strategies and maintain regular contact with investigators to support enrolment targets.
• Develop, maintain and review a study-level country risk management plan, managing sites, stakeholders, vendors and customers to ensure timely risk identification and mitigation.
• Coordinate closely with National Coordinating Investigator or National Lead Investigator on recruitment and other key study matters where applicable.
• Plan and lead National Investigator Meetings in line with local codes when required.
• Support forecasting for study timelines, resource needs, recruitment, budgeting, materials and investigational product supply.
• Ensure set-up, updating and access to business-critical systems for Safety Reporting, Regulatory Submissions and Clinical Trial Transparency at country level.
• Ensure accuracy and compliance of all study payments in accordance with local regulations and agreements.
• Participate in training and coaching of new Local Study Team members to ensure quality delivery and adherence to ICH-GCP and AstraZeneca procedures.
• Maintain the study eTMF in an inspection-ready state at all times, ensuring documentation is complete, accurate and current.
• Plan and lead audit and regulatory inspection activities in collaboration with the Clinical Quality Associate Director and Quality Assurance teams.
• Contribute insights to process development and continuous improvement initiatives across the organization.
• Keep line managers regularly informed about study status, milestones, key issues and team performance.
• Ensure full compliance with local policies, codes of ethics and business practices in all study-related activities.
• Provide feedback on research trends, competing studies and site/investigator insights that can inform local strategy.
• Collaborate with the local Medical Affairs team as needed to support optimal study delivery and scientific quality.
• Actively support SMM initiatives at local, regional or global level as agreed with line management.

Essential Skills/Experience

• Bachelor’s degree in related discipline with 5+ years of previous experience in the pharmaceutical industry
• Relevant knowledge and ability to fulfill key responsibilities, including but not limited to:

+ Drug development process and related GxP processes, International guidelines ICH-GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, Clinical Study Management including project management, monitoring, study drug handling and data management. + Personal Effectiveness & Drives Accountability in Others + Learning Agility + Financial, Technology & Process Competency + Active Listening, Fluency in written & spoken business-level English + Act with Integrity & high ethical standards + Effectively lead a team across in-person and virtual settings to deliver shared goals, demonstrates cultural awareness + Identify and champion more efficient delivery of quality clinical trials with optimized cost and time + Ability to travel nationally/internationally as required + Valid driving license, if country employment requirement + Communication & Teamwork – Influencing, Collaboration, Impactful Site conversations + Effective, risk-based thinking – Plans & Aligns, Strategic thinking, Problem Solving, Critical Thinking, + Decision Making, Effective Issue Management + Clinical Study Operations (GCP) & Quality Management – RbQM: Interpreting and implementing the Monitoring Plan, Study site selection & set-up + Deliver Priorities Results & Impact – Project Management, Recruitment/Retention Planning & Action

Desirable Skills/Experience

• Bachelor's degree in the life sciences field is preferred
• Previous experience in Clinical Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies) is a plus

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Based at our Gaithersburg headquarters, the role partners closely with HCP marketing, regional marketing, field sales, medical, market access and other key stakeholders to translate brand strategy into clear, compelling and scientifically robust speaker materials that enable consistent message pull-through and engagement.

Curious about how strategic content, operations and science come together to change clinical practice?

Accountabilities:

• Lead the P2P content strategy and promotional education roadmap for the Hematology Franchise, collaborating with HCP marketing to integrate data updates and brand messaging into speaker assets.

• Partner with cross-functional teams including regional marketing, brand marketing, field sales, medical affairs, market access and others to deliver a cohesive and impactful peer-to-peer strategy.

• Drive the development of branded and unbranded speaker decks, FAQs and supporting materials that are scientifically sound and aligned with brand objectives.

• Support the MLR review process for all P2P materials and assets, ensuring compliance with regulatory guidance and medical accuracy of content.

• Coordinate with brand and regional marketing teams to identify KOLs for marketing initiatives and brand-led campaigns.

• Contribute to congress planning, GPO services and P2P execution tactics that enhance promotional education in collaboration with Key Customer Marketing partners.

• Implement a measurement framework for content performance analytics in partnership with the I&A team; define and track KPIs such as deck utilization and engagement.

• Serve as KCT operations lead for franchise and business planning, budget management and integration between field and HQ marketers.

• Own First Line Monitoring and Quarterly Budget Plan responsibilities by gathering inputs from cross-functional partners and managing compliant, timely submissions.

• Ensure governance and compliance through content risk scanning, alignment with needs assessments and robust documentation standards for all P2P assets.

• Manage agency and vendor relationships, workflows, expense budgets, annual brand strategy planning and launch initiatives to deliver on franchise priorities.

Essential Skills/Experience:

• Bachelor’s Degree

• 3+ years of pharma or healthcare industry experience with Oncology therapy area experience

• Experience in one or more of the following: brand marketing, specialty sales, strategic planning, marketing operations, project management

• Experience managing agency partners and vendors

• Cross functional leadership and stakeholder management

• Comfort operating in a highly regulated environment and industry

• Effective communication and cross-functional teamwork skills

• Understanding of budget management across multiple projects and deliverables

• High ethical standards and personal integrity

Desirable Skills/Experience:

• 5+ years of pharma or healthcare industry experience with 2+ years of Oncology experience

• Strong project management, leadership, business acumen, and ability to manage multiple priorities, processes, timelines and expectations of multiple stakeholder groups

• Strong interpersonal skills and excellent verbal and written communication skills; able to engage with leadership at all levels of the organization; able to synthesize and concisely communicate team deliverables and accomplishments

• Experience with marketing operations including strategic oversight and execution of speaker bureau programs; strong comprehension of the legal and regulatory landscape in pharmaceutical promotions, pharma industry guidelines, and compliance considerations

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives 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.

AstraZeneca offers the opportunity to shape the future of cancer care by combining scientific rigor with strategic impact in a fast-evolving Oncology environment. Here, medical evidence is translated into real-world practice through close collaboration across Medical Affairs, Commercial and R&D, enabling teams to influence every point in the patient journey. Colleagues are encouraged to test bold ideas, learn from experience and share knowledge across functions, all within a supportive culture that values integrity, openness and continuous development. It is a place where high-performing people see their work directly contribute to advancing a strong pipeline and moving closer to eliminating cancer as a cause of death.

Ready to help transform hematology practice through impactful peer-to-peer education and strategic collaboration? Apply now.

The annual base pay for this position ranges from $193,898 to $242,373. Our positions offer eligibility for various incentives,an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

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