Clinical Study Manager

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As part of Ontada's Real World Research team, this role will lead the coordination and management of all activities for observational retrospective research studies focused on hematology/oncology. This role is accountable for the delivery of studies on time and within contracted scope. S/he will be an assertive leader who can "work through others" to ensure effective and efficient delivery according to study contracts while maintaining customer satisfaction. This role additionally requires excellence in cross-functional collaboration, with a high level of competence and skill in communication across disciplines and functional areas.

Key responsibilities:

• Provides operational oversight for studies, including accountability for delivering on time, in scope, within budget (where applicable), and in compliance with documented process & quality standards.
• Leads a cross-functional study team and proactively manages all aspects of study delivery, including coordinating all tasks within the study team
• Leads internal study meetings, including drafting agendas (with input from Scientific Lead), taking meeting minutes, recording decisions and tracking risks and action items until completion
• Generates content for and leads discussion of any operational topics on client-facing meetings, including discussions of timeline, scope, and process
• Ensures study team (including client) visibility to upcoming study milestones, and facilitates timely discussions of all other relevant topics
• Ensures project is conducted according to the project plan, coordinating with cross-functional team members as needed and ensuring the study timeline remains accurate and up to date, either directly or through close collaboration with the project scheduler
• Collaborates with key roles outside the study team to maintain the progress of study-related administrative activities.
• Monitors customer temperature and acts as a counterpoint to Scientific Lead to balance scientific excellence, contracted scope, and customer satisfaction.
• Demonstrates excellent influencing and stakeholder management skills.
• Embraces a digital mindset and effectively leverage technology to work efficiently within the study team, identifying new potential solutions where relevant
• Acts as a subject matter expert on Ontada's processes, ways of working, and written standards, contributes to departmental initiatives to improve how we work, and champions that work within our team
• Demonstrates leadership within the study team and the functional area for efficient and effective delivery of studies for our customers

Minimum Requirements:

• Typically 4+ years of professional experience leading or managing research studies in an industry environment (e.g., pharma/biotech, consulting)
• Working knowledge of research methods, specifically within the hematology/oncology therapeutic areas

Critical skills:

• Experience managing operational components of a research study including contract scope, budget, and timelines.
• Excellent at overseeing study operations, maintaining compliance with quality standards for research documentation, and managing tasks efficiently.
• Ability to manage a large volume of deliverables with varying deadlines across many projects, and flexibility to adapt to changing priorities in a fast-paced, dynamic environment
• Strong track record of effectively leading in a cross-functional setting, fostering collaboration and accountability
• A proactive mindset that excels at thinking outside the box to overcome obstacles, mitigate risks, and implement solutions collaboratively with limited oversight
• Exceptional stakeholder management skills, including engagement with external customers
• Demonstrated ability to influence without authority in order to drive a project forward
• Excellent written and verbal communication skills, including leading effective meetings and presentations and facilitating complex technical discussions
• Ability to effectively translate scientific discussion into actionable steps that can be implemented within the operational framework of the study.

• Maintains working knowledge of project management principles and the key systems associated with delivering RWR studies (e.g., Microsoft Project, Salesforce)

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, pleaseclick here.

McKesson is an Equal Opportunity Employer

McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

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