Prin Clinical Research Spec /Sr Clinical Research Spec ( Remote Role )

Job Title         :  Prin Clinical Research Spec

Location         :  6135 Gunbarrel Ave Boulder Colorado 80301

Duration         : 12 months (with possible extension)

Job Description 

Preferred candidate from local area but open to both remote possibilities as well.

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.

Other Responsibilities:

•           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.

DIFFERENTIATING FACTORS 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.