Clinical project manager

Petrovax is seeking a Project Manager (senior) to join our expanding team. Ideal candidates will have:

• Prior Clinical Project Management experience in the CRO/Pharmaceutical industry.
• Strong Global Clinical Trial experience across multiple therapeutic areas

BASIC FUNCTIONS:

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 and procedures. Supports the department director in development of functional training, 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 vendor relationships
• Ability to negotiate with all involved parts operational processes are maintained, projects are done within scope.
• Reviewing and identifying project study trends and proactively responding to all potential issues.
• 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
• Responsible for assuring project timelines.
• Responsible for identifying processes which need updating and documenting that to the direct line manager or divisional lead
• Responsible for maintaining involved parts 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 other Managers, as assigned
  • Oversee delegation of support staff activities, as necessary
  • Assists in the development and delivery of capability and proposal defense presentations as necessary
  • Supports Contracts and Proposals with final project scope. 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.

KNOWLEDGE, SKILLS AND ABILITIES:

• Knowledge of clinical research process from Phase I to III and Post-marketing through regulatory submission
• Strong communication skills (verbal and written) to express complex ideas
• Excellent 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 various 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
• Working knowledge of current ICH GCP guidelines

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Up to 10% travel may be required

MINIMUM RECRUITMENT STANDARDS:

Previous Management Requirements:

• MD or University degree US Bachelor Level or equivalent in a health-related field with a minimum of three (3) years direct clinical trial experience in a CRO or research-related organization with at least one (1) year management experience OR
• Equivalent level of education and experience.
• Previous experience in managing people within a scientific/clinical environment is preferred.

Data Management experience with metric estimation, queries resolution and data base lock required

Excellent and demonstrated verbal and written communication and presentation skills.

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.
• Experience in contract/timeline management preferred
• Excellent written and verbal communication skills required
• Ability to travel domestically

WE OFFER

• Dynamic environment, variety of nonstandard tasks and opportunity to use different approaches

• Career opportunity
• Competitive salary and good social package