Responsible for the successful planning, implementation and execution of contracted activities. Assures the accurate transfer of contracts from proposal through project completion. Functionally responsible for all team members throughout the duration of each clinical trial. Assures clear client communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures set forth by Novella and sponsors. Supports the department director in development of functional training, mentoring, and definition of standards and execution of department goals including process improvement.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Responsible for all activities related to implementation of clinical studies including:
• Manages projects of full scope regional and global projects. Responsible for project team leadership
• Responsible for building and maintaining positive client relationships
• Ability to negotiate with clients to assure Novella’s operational processes are maintained, projects are done within scope
• Reviewing and identifying project study trends and proactively responding to client and respective team members
• Developing appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzes information and develops innovative solutions to challenges
• Identifying, define, document training requirements in LMS systems and assure project level compliance with study specific training requirements
• Responsible for change management on all assigned projects
• Responsible for assuring projects assigned are run according to SOPs and WP as refined in the contract
• Responsible for assuring project timelines are met as per contract
• Responsible for identifying processes which need updating and documenting that to the direct line manager or divisional lead
• Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware
• In conjunction with management, assists with developing, documenting, and updating internal processes and processes required for consistency across programs such as SOPs, working practices, and related quality assurance forms.
• Provide other project support to Managers, as assigned
• Oversee delegation of support staff activities, as necessary
• Assists in the development and delivery of capability and proposal defense presentations to prospective clients
• Supports Contracts and Proposals with final project contract execution and CIS documentation by the project team. Represents senior management in negotiation of contracts as appropriate.
• Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annually
• Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.
• Responsible to maintain personal currency documentation for Novella SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff at each and every instance of out of office
KNOWLEDGE, SKILLS AND ABILITIES:
• Thorough knowledge of clinical research process from Phase I through regulatory submission
• Strong communication skills (verbal and written) to express complex ideas
• Excellent and demonstrated organizational and interpersonal skills
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
• Ability to manage multiple priorities within a variety of complex clinical trials
• Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings
• Ability to set baseline targets, track trends and implement mitigation plans
• Understanding of basic data processing functions, including electronic data capture
• Demonstrated problem-solving and financial negotiation skills.
• Working knowledge of current ICH GCP guidelines
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
• Very limited physical effort required to perform normal job duties.
• Up to 20% travel may be required including international travel
• Must be able to secure a credit card cosigned by Novella
MINIMUM RECRUITMENT STANDARDS:
• Previous Management Requirements:
Nursing or University degree (US Bachelor Level or equivalent) in a health-related field with at least five (5) years direct clinical trial experience in a CRO or research-related organization with at least two (2) years management experience OR
Equivalent level of education and experience.
Previous experience in managing people within a scientific/clinical environment is required.
• Demonstrated Clinical Monitoring and/or Data Management experience required.
• Excellent verbal and written communication and presentation skills required.
• Demonstrated financial management skills required
• Ability to work independently, prioritize and work with in a matrix team environment is essential.
• Working knowledge of Word, Excel, and PowerPoint required.
• Prior experience in electronic data capture preferred.
• Ability to travel domestically or internationally as required.