Manager, Start Up

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.