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 startup 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 candidates 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.