Manager, Study Start Up

Premier Research Group Limited - Research Triangle Park, NC (30+ days ago)


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 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
Can work globally
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 establishing career path 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 site recruitment, study start up, maintenance and close out
Other activities as designated

REQUIREMENTS:
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

Minimum of 5-7 years of clinical research industry required

Ability to handle multiple task to meet deadlines in a dynamic and changing environment is essential.
3+ years people management experience
Knowledge of ICH / GCP regulations
Working knowledge of FDA Guidance Documents / EU Directives / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
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
Basic knowledge of the principals of project management
Fluent verbal and written English as well as the local language(s) required for clinical trial submissions
Excellent team player, collaborative and able to build an effective team
Ability to multitask and work effectively in a fast-paced environment with changing priorities
Strong verbal and written communication and negotiation skills
Excellent 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