Manager, Study Start-Up Services
Premier Research - Raleigh, NC

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Responsible for site identification and feasibility assessments for both contracted project work and in support of business development efforts for future work in all appropriate core therapeutic areas within the corporate portfolio. Collaborates with other skill centers to strengthen the company's ability to launch larger Phase III multi-center programs and smaller programs with aggressive timelines by way of employing innovative processes to support the front end critical path tasks. Responsible for the continual development, expansion, maintenance and management of Premier Research Investigator Database to capture Investigator experience and capabilities, as well as quality metrics regarding actual performance on Premier Research trials. Provides leadership in the implementation of operational management activities and participate in the development and revision of CTM policy.

Develops and maintains standard tools for site identification and feasibility assessments inclusive of activity trackers, feasibility templates, and communication templates

Conducts and summarizes preliminary feasibility assessments as requested to support business development efforts. Participates in proposal/algorithm preparation and review, as appropriate

Conducts site identification and feasibility assessments for contracted projects and collaborates with project team and sponsor in final site selection.

Manages the maintenance and expansion of reporting capabilities of the Premier Research Investigator Database

Establishes and nurtures collaborative relationships with expanding group of preferred sites in core therapeutic areas

Identifies and optimizes efficiencies of study start-up processes in continued effort to streamline processes and condense start-up cycle times without compromising quality. This will include establishment of performance management metrics and quality initiatives

Provides all aspects of line management supervision to staff including, but not limited to, performance management (quality, quantity and timeliness of work performed), guidance on corporate policy, training and support

Assists in staffing activities such as recruiting, hiring, interviewing, proposal and budget development, resource assignments, and retention of high quality staff

For each direct report, maintains retrospective and prospective vigilance of utilization, availability to take on additional work, ELT, and employee satisfaction PRIMARY JOB FUNCTIONS (Continued):

Promotes a strong team approach to ensure project alignment through active collaboration and communication with Project Management, CMS and other applicable skill centers

Works with Project Management, as well as Medical Management and Safety, to acquire effective therapeutic and project specific training for Study Start-Up staff, as appropriate

Manages individuals in office-based or remote locations and ensures they have proper equipment and setup to function effectively

All other projects as assigned

Required Skills

Required Experience

Minimum of a recognized four year undergraduate degree in biological sciences or related field, or RN with clinically relevant experience is required, advanced degree is preferred

Special knowledge of clinical monitoring operations/functions, application of regulatory compliance guidelines, CRO operations and medical terminology

Proven effective management and leadership skills

Ability to motivate, nurture and mentor staff

Excellent communication skills (interpersonal, written, verbal)

Attention to detail and strong organizational and time management skills

In depth understanding of the importance of industry best practices, clinical performance and productivity toward implementation of study plans and study progress

Strong interpersonal and customer service orientation for internal and external associates to proactively identify and resolve issues

Demonstrated Knowledge of FDA/ICH guidelines and GCPs

Expanded knowledge of Microsoft Word, Excel for Windows, and ability to attain knowledge of Lotus Notes, MS Access, MS Publisher, PowerPoint and Visio

Ability to travel up to 33% with some overnight stays expected

Ability to obtain American Express credit card, or equivalent, valid driver's license etc.

Minimum of five years experience in the pharmaceutical or related industry in a

Clinical research capacity, minimum two years in field monitoring experience as a clinical research associate (CRA, SCRA or the equivalent) and one year in clinical lead role is preferred

At least two years of prior line management and mentoring supervisory experience is required; project management and budgetary responsibility experience preferred

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