You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
What You'll Be Doing:
Manages staffing and resources to ensure departmental utilization
Drives study start up teams to meet project timelines
Assists in determining efficiencies for study start up to continually improve and streamline current processes without compromising quality
Assists in determining efficiencies for essential document maintenance to continually improve and streamline current processes without compromising quality
Assists in proactively moving the department forward through involvement of corporate initiatives
Performs additional duties and assignments as requested
Performs all aspects of managing/mentoring direct reports for HR items, training and performance management
Manages and motivates direct reports with project and people management responsibilities
Works independently as well as a part of a team
Creates and evaluates performance objective for direct reports
Prioritizes multiple assignments in a fast-paced work environment
Maintains spreadsheets regarding metrics and provides monthly updates to upper management or as needed
Applies analytic skills to reports and feasibility in the Study Planning stage
Works within an organized and highly developed problem-solving environment
Maintains working knowledge of costing for tasks involved with Study Start Up and sourcing staff
Recommends measures to reduce costs for Premier Research, when appropriate
Contributes to aspects of business development, including evaluating and defining proposal specifications
Presents to clients as needed or required
Utilizes technology in search capabilities for Study Planning
Ensures department staff is current on company SOPs as well as updates to industry regulations and guidelines
Meets with staff regularly to ensure that studies are on target to meet timelines
Works in a global environment and coordinates multiple countries
Manages resourcing and staffing of new studies awarded to Premier Research to ensure that studies are adequately staffed and timelines are met
Prepares forecasts for staff utilization over the life of the study
Ensures appropriate transition planning and stakeholder communication for any staff changes
Provides Time Entry Guidelines to the clinical staff and applicable training
Identifies out-of-scope tasks from the clinical team and ensures pre-approval of these tasks
Completes performance evaluation for direct reports for annual appraisals
Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and ADs related to study start-up
Mentors staff, as applicable, and works closely with staff for career pathing to ensure growth in the company as desired
Participates in corporate initiatives and actions that ensure the continued success of the company
Acts as a resource for other Managers and seek opportunities to share knowledge base
Recognizes strategic opportunities to improve department productivity
Develops training and implementation for own staff, as well as other departments
Produces succinct documentation and presentation for both internal and external use with minimal input from upper management
Establishes harmonized process for study start up, maintenance and close out
What We Are Searching For:
Undergraduate degree or its international equivalent in clinical, science, or a health-related field from and accredited institution; a licensed health-care professional (i.e. registered nurse); or equivalent work experience required
5+ years of clinical research industry experience required
1+ years people management experience
Analytic skill set to review metrics and feasibility numbers
Working knowledge of FDA, European Regulatory and EC procedures as applicable
Ability to handle multiple task to meet deadlines in a dynamic and changing environment is essential.
Working knowledge of ICH / GCP regulations
Strong knowledge of web-based communication tools for conferences and any other IT systems required for the job
Knowledge of national/local health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site start up activities will be carried out
Knowledge of the principals of project management
Excellent team player, collaborative and able to build an effective team
Good verbal and written communication and negotiation skills
Good organizational and time-management skills, able to prioritize work to meet deadlines
Accountable, dependable and strong commitment
Customer service focused in approach to work, both internally and externally
Maintains a positive, results orientated work environment
Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $100,000 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status
Skills Required
- Undergraduate degree or international equivalent in clinical, science, or health-related field; licensed healthcare professional; or equivalent work experience
- 5+ years of clinical research industry experience
- 1+ years of people management experience
- Analytical skills for reviewing metrics and feasibility data
- Working knowledge of FDA, European regulatory, and EC procedures
- Ability to manage multiple tasks and deadlines in a dynamic environment
- Working knowledge of ICH and GCP regulations
- Knowledge of web-based communication tools and required IT systems
- Knowledge of national and local health systems and relevant regional cultural and professional practices
- Knowledge of project management principles
- Excellent teamwork, collaboration, and team-building skills
- Strong verbal, written communication, and negotiation skills
- Strong organizational and time-management skills
- Accountability, dependability, and strong commitment
- Customer-service-focused approach
What We Do
We’re out to change the course of medical science. Are you ready to rise to the challenge? Premier Research is not about being everything to everyone. Instead, our deep, focused expertise targets the therapeutic areas and indications where today’s biotech and specialty pharma pioneers are doing the most amazing work. We’re 1,500 employees strong and operate in more than 20 countries, delivering unmatched expertise, operational skills, and dedication to meeting customers’ most challenging needs. Join us and meet some of the brightest minds in clinical development today — people who apply their best thinking to every project, recognizing that what they do significantly affects the lives and well-being of customers, patients, physicians, and colleagues. You’ll enjoy great benefits and very flexible working conditions in a company that values your contributions, rewards your achievements, and is committed to helping you reach your full potential. Are you ready to make a real difference and help us transform this exciting industry? Follow our company page for more information about us and the work we do, and check out our current openings for your next career move!
