Control and coordination of all aspects of executing assigned projects. Organizing, planning, reporting, analysis, design and prioritizing work objectives. Optimization of work flow. Definition of project deliverables and work breakdown structure, assignment of tasks and directing project activities. Preparation and submission of all required reports to internal and external stakeholders. Maintenance of project/program records.
Ensure that work product complies with design and performance standards, regulatory environment and customer expectations.
Enforce standards applicable to each step in project execution.
Detailed preparation, maintenance and reporting of project costs and overall budget. Financial tracking of project expenses and client billing.
Estimating, acquiring and allocation of human and material resources.
Management of third party vendors.
Assessing and mitigating technical, project and business risks.
Identifies, develops, and implements appropriate productivity metrics related to project budgets and schedules for use in monitoring, tracking and controlling performance and for use projecting future trends related to cost, completion time and resource needs.
Provides leadership to ensure successful transfer of projects from sales and marketing to operational control and execution. Proactively anticipates and facilitates future business opportunities with existing and prospective clients.
Management of Daily Activities:
Manage all resources and tasks in an efficient manner, including collaboration with colleagues, with the objective of achieving successful completion of assigned project tasks in accordance with our Standard Operating Procedures.
Ensure all quality procedures are carried out according to our procedures.
Confirm all incoming and outgoing shipments are tracked in a timely and accurate manner.
Review and approve all documentation associated with project(s) as required.
Coordinate and/or conduct investigations to resolve data discrepancies and reconcile data as appropriate.
Enforce GMP/GLP/ISO/safety regulations and standards.
Maintain and support safe lab practices and environment.
Professionally and positively represent the Company by endorsing and supporting company decisions to influence staff buy in without conflict.
Communications & Reporting:
Communicate with clients and collaborators with regard to data management, specimen tracking and processing both internally and externally.
Assist clients, collaborators and senior management in the implementation of new studies and protocols.
Prepare reports and correspondence to clients and collaborators, and department Director as required.
Make recommendations on new business opportunities as appropriate.
Maintain contract/project financial data, including labor hours/dollars and materials.
Evaluate contract/project budgets on a monthly basis and report unexpected variances to department Director.
Assist in bidding on new projects, writing proposals, and preparing budgets.
Assist in the development and implementation of new repository projects.
Act/ Serve as a mentor to staff within the organization.
Perform other duties as assigned by management.
Bachelor’s Degree in Life Sciences or related field preferred. Master’s Degree highly desired.
PMI Certification preferred.
Must exhibit strong leadership skills and meet high performance work culture standards.
Requires excellent communication, interpersonal, organizational and multi-tasking skills.
Must have demonstrated success in partnering with sales and marketing to bring in new business, manage customer expectations and bring projects to closure.
Must possess strong computer and business writing skills.
Experience with Microsoft Office and Microsoft Project required.
The successful candidate will have a proven track record of coordination and communication with personnel across disparate technical and business backgrounds such as R&D, Marketing, Sales, Manufacturing, Executive Management, Quality Assurance and Regulatory Affairs.
Extended work hours may be necessary in order to meet business demands.
Periodic travel may be required to meet business demands.
2-5 years clinical trial project management experience in medical device and/or IVD clinical trials
Must be able to read, write, speak fluently and comprehend the English language
Candidates familiar with GCP, GLP, GMP, CLIA, and ISO regulatory guidelines will be given special consideration.