Clinical Study Manager Jobs in Indiana (NOW HIRING)

QVIA Biotech is seeking an Associate Clinical Project Management, Director:

IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.

Job Overview
Manage and support the operational elements and execution of studies and/or programs to ensure delivery; time and quality resulting in strong financial performance and customer satisfaction and in accordance with SOPs; policies and practices from pre-award to close-out. Work with study(ies)/program(s) teams to focus on leveraging deep therapeutic expertise and IQVIA solutions to drive operational excellence and strategic leadership with our customers.

Essential Functions
Participate in bid defense preparations. Lead bid defense presentations in partnership with Business Development for large sized, multiple and full service, multiple country and/or multi regional studies. Understand project strategy and operationalize the agreed upon approach.
Develop and/or support on the preparation of integrated study management plans in collaboration with the core project team.
Accountable for the strategic development and execution or delivery of clinical studies in line with agreed upon contracts while optimizing speed, quality and cost of delivery, ensuring consistent use of study tools and training materials and compliance with system updates, standard processes, policies and procedures.
Serve as primary project oversight and/or contact with customers and own relationship with the project's key customer contact(s), communicate/collaborate with IQVIA business development representatives as necessary.;
Set objectives for the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance, providing feedback and leadership.
Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally.
Supervise problem solving and resolution efforts to include management of risk, contingencies and issues. Take accountability for proactive contingency plans to mitigate risks.
Coach and/or mentor junior team members around project delivery, planning, project review, risk management and problem solving to ensure global alignment of work practices across the team.
Achieve project quality by identifying and proactively managing quality risks and issues, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans.
May participate in executive committees as part of program leadership.
Ensure the financial success of the project including optimal management and assignment of resources to achieve project goals and profitability.
Forecast and identify opportunities to accelerate activities to bring milestones and revenue forward, implement appropriate actions to achieve.;
Identify changes in scope and manage change control process, including securing customer agreement to financial and milestone updates as necessary.
Identify and communicate lessons learned and best practices to promote continuous improvement.
Adopt corporate initiatives and changes, and serve as a change advocate when necessary.
Provide input to line managers on their project team members' performance relative to project tasks. Support staff development. Mentor less experienced project team members on assigned projects to support their professional development.

Qualifications
Bachelor's Degree Life sciences or related field.
Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.
Requires 10 years clinical research experience including 6 years of project management experience or equivalent combination of education, training and experience.
Knowledge of clinical trials - Knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge, therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.
Communication - Strong written and verbal communication skills including good command of English language Strong presentation skills. Requires strong negotiation and customer management skills.
Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently. Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
Finances - Good understanding of project financials including experience managing, contractual obligations and implications.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more athttps://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.