Prin Clinical Research Spec
6165 Gunbarrel Avenue Boulder, CO 80301 US
Pay range 54-61/h depending on experience.
Top skills needed: Good understanding and critical experience in clinical study/research management, experience in writing clinical protocols and clinical site management experience
Responsibilities may include the following and other duties may be assigned
- Oversees, designs, plans and develops clinical research studies. May be involved in early study development including statistical design of the trial.
- Prepares and authors protocols, informed consent forms, and study plans.
- Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
- Assists in overseeing and interpreting results of clinical investigations in preparation for new device or consumer application / device indication. Oversees and resolves operational aspects of clinical studies in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations
- Ownership in preparation of clinical study budgets, track budgets and timelines.
- Oversees clinical study operations performed by other team members, including safety, monitoring, data management, and site and vendor selection.
- Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
- Escalates any study issues quickly to leadership. Ensures study milestones are met and mitigate timeline risks
- Maintains understanding of regulatory requirements across multiple regions.
- May serve as resource for clinical strategy personnel in the hybrid role of CES supporting CPMs.
- May represent Clinical Affairs team on certain product core teams providing Subject Matter Expert support with clinical requirements in accordance with SOPs and regulations.
- Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and clinical leadership.
- Reviews the status of projects and budgets; manages schedules and prepares status reports.
- Assesses project issues and develops resolutions to meet productivity, quality, and objectives. Develops mechanisms for monitoring project progress and for intervention and problem solving
- Present to and partner with clinical leadership on the overall health of the portfolio, successes, and areas of opportunity.
- Organizational Impact: May be responsible for entire projects or processes within job area.
- Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
- Makes improvements of processes, systems, or products to enhance performance of the job area.
- Analysis provided is in-depth in nature and often provides recommendations on process improvements.
- Exchange information of facts, statuses, ideas, and issues to achieve the business objective, and influence decision-making.
Autonomy: Recognized expert, managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager . Coaches, reviews and delegates work to lower level specialists.
Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results . May manage large projects or processes that span outside of immediate job area.
Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation . Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems.
Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement, and influence decisionmaking.
Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.
Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
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