Associate Start Up Lead
Serbia, Romania, Hungary, Slovakia or PolandFull-TimeLead
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 3 years or more
Requirements
- Bachelor's degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience
- 3 years or more in start-up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/biotech industry
- 1 year or more experience in project milestone management, managing resources, budgets and coordinating team activities
- 1 year or more experience presenting to clients
- Demonstrated leadership experience in driving cross functional activities
- Excellent communication and organizational skills
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail
- Fluency in English and for non-English speaking countries the local language of country where position based
- Experience using milestone tracking tools/systems
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information
- Excellent organizational skills
- Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
- Ability to work independently in a fast-paced environment with a sense of urgency
- Excellent computer skills
- Excellent time management and prioritization skills to ensure deadlines are met
- Excellent communication, presentation, interpersonal skills, both written and spoken
Responsibilities
- Manage the site start up process through development of an activation readiness strategy.
- Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy (if assigned to global study), ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
- Collaborate and communicate with stakeholders for milestone planning and alignment of operational goals.
- Participate in client meetings to establish expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics.
- Partner closely with Functional Leaders and Site Start up Specialists to proactively identify and mitigate risks to timelines.
- Provide oversight to ensure accuracy and completeness of agreed tracking and systems for progress metrics.
- Responsible to co-ordinate translations for documents required for submissions.
- Maintain communication with other key functions like Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group.
- Act as SME for collection and maintenance of site level critical path to IMP Release data points.
- Directly support country or site level activities start up activities if needed.
- Support development of country specific Country Start-up summary and process flow.
- Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
- May mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
- Interact with clients in proposal activities, including slide development and client presentation.
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