What you will be doing:
This position will be accountable for assuring the successful implementation of projects through project leadership and the management of multiple project managers and stakeholders. This position will lead development of the study protocol and statistical analysis plan, oversee the day-to-day work of the project, coordinate project managers as well as internal and external stakeholders, and uphold Premier’s research policies in addition to all applicable federal and state regulations for research. This position will lead strategic efforts within PAS including developing standard operating procedures and procedures related to research processes, especially those focused on regulations and compliance. The Senior Director will also lead or support business development opportunities including drafting proposals, statements of work and interacting with potential sponsors.
This position will interact daily with the client as well as other stakeholders, those from the biopharmaceutical or medical device industries, medical societies, government agencies, consulting organizations, and hospitals and health systems. This position has significant responsibility for coordinating, under the direction of the Principal Investigator (PI), client-funded projects in such areas as real-world evidence outcomes research, implementation research, comparative effectiveness, safety, clinical informatics, Pharmacoeconomics, quality improvement and other fee for service-related work primarily through prospective designs. When needed and as appropriate, these positions will serve as PI for funded projects. These projects are complex, often involving multiple teams across Premier who have their own project management processes. This position is expected to manage those efforts so that the client and other stakeholders have a seamless experience. This position manages the project timeline, identifies risks to the timeline and protocol and ensures that potential problems and potential solutions are brought to the PI’s attention as soon as possible. Senior Directors are expected to keep abreast of any new studies and/or grey literature that may release after the protocol is developed and may impact the study.
Key Responsibilities
Responsibility #1 – 85%
Study Leadership
• Lead Applied Sciences studies from proposal development through final deliverable, with PI oversight as needed
• Develop a study timeline with key milestones and metrics to ensure the successful delivery of the study
• Identify and align team resources required for each study component
• Ensure completion of deliverables according to established deadlines by identifying potential risks to the study and possible solutions to potential risks
• Be viewed as a leader by all stakeholders involved in the study and maintain an executive presence
• Lead face-to-face meetings with client – including the intervention design session(s) and learning sessions which may include Client staff, KOLs, Premier staff, and hospital staff.
• Contribute to presentations/publications as warranted
• Demonstrate active leadership in the management of Life Science studies and projects
• Contribute to successful study execution through the coordination of various project managers
• Serves as the primary contact for clients and other stakeholders
• Supports the Principal Investigator (PI) to ensure that the study is successfully executed and that all risks to the study are managed
• As needed, serve as Principal Investigator with responsibility to direct the study, manage risks to the study and assume ultimate responsibility for the study, including all regulatory tasks.
• Oversees successful study execution by supporting site recruitment and management, SME recruitment and management and study steering committee management
• Actively identify potential barriers to successful milestone delivery
• Ensure appropriate documentation
• Oversee the creation and maintenance of shared folders for each project, following Premier standard operating procedures
• Lead the development of interventional materials based on evidence-based practices
• Promote adherence to Premier’s research policies to all involved in Applied Sciences studies
• Manage project budget and monitor for any potential problems; keep PI informed of these potential problems and possible solutions
• Work across the business unit to deliver quality products to our clients and to track and maintain excellent customer satisfaction
• Provide an environment that fosters continuous process improvement, product innovation and knowledge sharing designed to help Premier meet and exceed customer expectations
Responsibility #2 – 15%
Strategic Oversight of Methodologies, Tools and Services
• Lead efforts to develop the standard operation procedures and policies for studies to ensure regulatory compliance.
• Develop, enhance and standardize an array of tools and methodologies and assure consistent practices within Applied Sciences
• Tools: Project management and coordination, executive profitability reporting, sponsor surveys
• Lead processes to support study requests, report writing and presentation materials
• Lead processes, methodologies and templates for milestone tracking, meeting agendas, meeting notes, action item tracking
• Lead team in development and implementation of a standard quantitative and qualitative process to conduct project-specific quality reviews (monthly, biweekly, or as needed); report results and recommend appropriate improvement actions
Required Qualifications
Work Experience:
Years of Applicable Experience – 10 or more years
Education:
Bachelors (Required)
Preferred Qualifications
Skills:
• Clinical research project management
• Peer review publication experience
• Interpreting and communicating clinical and comparative data
Experience:
• Project Leadership
• Business Development
• Clinical Data
Education:
• Master’s Degree
• Clinical Research Training
• CITI Good Clinical Practice
Additional Job Requirements:
• Remain in a stationary position for prolonged periods of time
• Be adaptive and change priorities quickly; meet deadlines
• Attention to detail
• Operate computer programs and software
• Ability to communicate effectively with audiences in person and in electronic formats.
• Day-to-day contact with others (co-workers and/or the public)
• Making independent decisions
• Ability to work in a collaborative business environment in close quarters with peers and varying interruptions
Working Conditions: Remote
Travel Requirements: Travel 21-40% within the US
Physical Demands: Sedentary: Exerting up to 10 pounds of force occasionally, and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves remaining stationary most of the time. Jobs are sedentary if movement is required only occasionally, and all other sedentary criteria are met.
Premier’s compensation philosophy is to ensure that compensation is reasonable, equitable, and competitive in order to attract and retain talented and highly skilled employees. Premier’s internal salary range for this role is $125,000 – $231,000. Final salary is dependent upon several market factors including, but not limited to, departmental budgets, internal equity, education, unique skills/experience, and geographic location. Premier utilizes a wide-range salary structure to allow base salary flexibility within our ranges.
Employees also receive access to the following benefits:
• Health, dental, vision, life and disability insurance
• 401k retirement program
• Paid time off
• Participation in Premier’s employee incentive plans
• Tuition reimbursement and professional development opportunities
Premier at a glance:
• Ranked #1 on Charlotte’s Healthiest Employers list for 2019, 2020 and 2022, and 49th Healthiest Employer in America (2022)
• Named one of the World’s Most Ethical Companies® by Ethisphere® Institute for the 13th year in a row
• The only company to be recognized by KLAS twice for Overall Healthcare Management Consulting
Employees receive:
• Perks and discounts
• Access to on-site and online exercise classes
• Paid time off to volunteer in their communities
Premier is looking for smart, agile individuals like you to help us transform the healthcare industry. Here you will find critical thinkers who have the freedom to make an impact. Colleagues who share your thirst to learn more and do things better. Teammates committed to improving the health of a nation. See why incredible challenges require incredible people.
Premier is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to unlawful discrimination because of their age, race, color, religion, national origin, ancestry, citizenship status, sex, sexual orientation, gender identity, gender expression, marital status, familial status, pregnancy status, genetic information, status as a victim of domestic violence, covered military or protected veteran status (e.g., status as a Vietnam Era veteran, disabled veteran, special disabled veteran, Armed Forces Serviced Medal veteran, recently separated veteran, or other protected veteran) disability, or any other applicable federal, state or local protected class, trait or status or that of persons with whom an applicant associates. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. In addition, as a federal contractor, Premier complies with government regulations, including affirmative action responsibilities, where they apply.
Premier also provides reasonable accommodations to qualified individuals with a disability or those who have a sincerely held religious belief. If you need assistance in the application process, please reply to [email protected] or contact Premier Recruiting at 704.816.5200.
Information collected and processed as part of any job application you choose to submit to Premier is subject to Premier’s Privacy Policy.
Location: , , US
Offer Expires: 2024-10-25 21:59:29
Job Posting Language: en
Benefits:
- Retirement Savings
- Dental Coverage
- Paid Time Off
- Health Insurance
Qualifications:
- Years of Applicable Experience – 10 or more years
- Bachelors (Required)
- Clinical research project management
- Peer review publication experience
- Interpreting and communicating clinical and comparative data
- Project Leadership
- Master's Degree
- Be adaptive and change priorities quickly; meet deadlines
- Attention to detail
- Operate computer programs and software
- Ability to communicate effectively with audiences in person and in electronic formats
- Day-to-day contact with others (co-workers and/or the public)
- Making independent decisions
- Ability to work in a collaborative business environment in close quarters with peers and varying interruptions
- Travel Requirements: Travel 21-40% within the US
- Physical Demands: Sedentary: Exerting up to 10 pounds of force occasionally, and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body
Responsibilities:
- This position will be accountable for assuring the successful implementation of projects through project leadership and the management of multiple project managers and stakeholders
- This position will lead development of the study protocol and statistical analysis plan, oversee the day-to-day work of the project, coordinate project managers as well as internal and external stakeholders, and uphold Premier’s research policies in addition to all applicable federal and state regulations for research
- This position will lead strategic efforts within PAS including developing standard operating procedures and procedures related to research processes, especially those focused on regulations and compliance
- The Senior Director will also lead or support business development opportunities including drafting proposals, statements of work and interacting with potential sponsors
- This position will interact daily with the client as well as other stakeholders, those from the biopharmaceutical or medical device industries, medical societies, government agencies, consulting organizations, and hospitals and health systems
- This position has significant responsibility for coordinating, under the direction of the Principal Investigator (PI), client-funded projects in such areas as real-world evidence outcomes research, implementation research, comparative effectiveness, safety, clinical informatics, Pharmacoeconomics, quality improvement and other fee for service-related work primarily through prospective designs
- These projects are complex, often involving multiple teams across Premier who have their own project management processes
- This position is expected to manage those efforts so that the client and other stakeholders have a seamless experience
- This position manages the project timeline, identifies risks to the timeline and protocol and ensures that potential problems and potential solutions are brought to the PI’s attention as soon as possible
- Senior Directors are expected to keep abreast of any new studies and/or grey literature that may release after the protocol is developed and may impact the study
- Responsibility #1 – 85%
- Lead Applied Sciences studies from proposal development through final deliverable, with PI oversight as needed
- Develop a study timeline with key milestones and metrics to ensure the successful delivery of the study
- Identify and align team resources required for each study component
- Ensure completion of deliverables according to established deadlines by identifying potential risks to the study and possible solutions to potential risks
- Be viewed as a leader by all stakeholders involved in the study and maintain an executive presence
- Lead face-to-face meetings with client – including the intervention design session(s) and learning sessions which may include Client staff, KOLs, Premier staff, and hospital staff
- Contribute to presentations/publications as warranted
- Demonstrate active leadership in the management of Life Science studies and projects
- Contribute to successful study execution through the coordination of various project managers
- Serves as the primary contact for clients and other stakeholders
- Supports the Principal Investigator (PI) to ensure that the study is successfully executed and that all risks to the study are managed
- As needed, serve as Principal Investigator with responsibility to direct the study, manage risks to the study and assume ultimate responsibility for the study, including all regulatory tasks
- Oversees successful study execution by supporting site recruitment and management, SME recruitment and management and study steering committee management
- Actively identify potential barriers to successful milestone delivery
- Ensure appropriate documentation
- Oversee the creation and maintenance of shared folders for each project, following Premier standard operating procedures
- Lead the development of interventional materials based on evidence-based practices
- Promote adherence to Premier’s research policies to all involved in Applied Sciences studies
- Manage project budget and monitor for any potential problems; keep PI informed of these potential problems and possible solutions
- Work across the business unit to deliver quality products to our clients and to track and maintain excellent customer satisfaction
- Provide an environment that fosters continuous process improvement, product innovation and knowledge sharing designed to help Premier meet and exceed customer expectations
- Responsibility #2 – 15%
- Strategic Oversight of Methodologies, Tools and Services
- Lead efforts to develop the standard operation procedures and policies for studies to ensure regulatory compliance
- Develop, enhance and standardize an array of tools and methodologies and assure consistent practices within Applied Sciences
- Tools: Project management and coordination, executive profitability reporting, sponsor surveys
- Lead processes to support study requests, report writing and presentation materials
- Lead processes, methodologies and templates for milestone tracking, meeting agendas, meeting notes, action item tracking
- Lead team in development and implementation of a standard quantitative and qualitative process to conduct project-specific quality reviews (monthly, biweekly, or as needed); report results and recommend appropriate improvement actions
- Sedentary work involves remaining stationary most of the time
Benefits:
- Premier’s internal salary range for this role is $125,000 – $231,000
- Final salary is dependent upon several market factors including, but not limited to, departmental budgets, internal equity, education, unique skills/experience, and geographic location
- Premier utilizes a wide-range salary structure to allow base salary flexibility within our ranges
- Employees also receive access to the following benefits:
- Health, dental, vision, life and disability insurance
- 401k retirement program
- Participation in Premier’s employee incentive plans
- Tuition reimbursement and professional development opportunities
- Perks and discounts
- Access to on-site and online exercise classes
- Paid time off to volunteer in their communities
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