Manager, Clinical Project

POSITION SUMMARY:
This position will manage clinical research projects, including key activities of landmark, global clinical trials, in a fast-paced environment with a focus on planning, execution and management of all operational aspects. Interfaces with the VP and Director, Clinical Affairs, and senior managers to provide tactical/operational leadership to members of the clinical study team, including cross-functional departments which support the clinical development process. [e.g., Clinical Research Associates (CRAs), Regulatory Affairs, Medical Affairs, Scientific Affairs, Biostatistics, Statistical Programming, Medical Writing, Data Management, Quality Assurance, Safety].
ESSENTIAL FUNCTIONS OF THE POSITION:

• Leads, executes, and monitors progress and performance of assigned clinical studies and programs globally, in accordance with strategy, project plans, and budget following applicable regulatory and standard operating procedures.
• Oversees the development of and collaborates with the study team on key team trial deliverables, such as protocols, informed consent documents, case report forms, trial guidelines, annual progress reports and final reports, including sponsor required regulatory submissions.
• Drives identification, qualification, and selection of clinical sites.
• Ensures clinical studies maintain a continuous state of audit readiness.
• Leads proactive identification, assessment, and management of clinical study risks.
• Informs and presents study progress and known risks to senior leadership.
• Selects and manages ongoing relationships with external vendors (i.e., CROs, core labs, central IRB, etc.) or contractors.
• Oversees contracts & other agreement for all aspects of assigned clinical studies.
• Oversees development of Clinical Monitoring Plan(s) and adequate monitoring of clinical study sites.
• Responsible for the conduct of site trial training and investigator meetings.
• Provides support to clinical investigators and site coordinators to resolve site-related issues.
• Manages day-to-day project activities of CRAs assigned to specific projects & provides project direction.
• Manages escalation of study related issues and establishes appropriate course of action/mitigation plans.
• Ensures adequate clinical data collection and follow-up compliance.
• Participates in study data review and interpretation, as well as oversight of clinical report writing.
• Thorough understanding of project management tools/techniques.
• Serves on various teams & represents the clinical department as needed.
• Participates in departmental developmental initiatives (e.g., training, SOP development, audit preparedness, etc.)
• Comprehensive knowledge of ISO (International Organization for Standardization), GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA (Food & Drug Administration) & other applicable regulations governing the conduct of clinical trials.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Ability to remove roadblocks, manage study teams directly and indirectly to drive clinical studies and projects to on-time and within budget completions.
• Ability to gather information from multiple sources, analyze, integrate, and resolve any conflicting requirements, and drive the clinical affairs organization through any challenges to result in a successful clinical study.
• Regular and predictable work performance.
• Ability to work under fast-paced conditions.
• Ability to make decisions and use good judgment.
• Ability to prioritize various duties and multitask as required.
• Ability to successfully work with others.
• Ability to understand deliverables form cross-functional teams.
• Ability to manage clinical affairs cross-functional team without direct influence.
• Additional duties as assigned.

BASIC QUALIFICATIONS:

• BS in a science or related technical field, including a minimum of 6 years of related work experience or an equivalent combination of education and work experience.
• 2+ years of experience managing medical device clinical trials.
• Broad knowledge and cross-functional understanding of clinical trials methodology and cross-functional team deliverables.
• Excellent oral and written communication skills.
• Working knowledge of Microsoft Office and Microsoft Project.
• Written/Report Writing Skills.
• Problem Solving/Trouble Shooting experience.

PREFERRED QUALIFICATIONS:

• Supervisory/Management experience.
• Project management experience with medical device clinical trials.
• Clinical budget management experience/financial acumen.
• Auditing experience.
• Regulatory experience.
• Ability to maintain a strategic perspective and align activities with business vision and purpose.
• Ability to respond flexibly and positively under conditions of uncertainty or change.
• ACRP or equivalent license/certification.
• PMP or equivalent license/certification.

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed.
• Ability to occasionally bend and push/pull as needed.
• Ability to pass pre-employment drug screen and background check.
• Ability to travel up to 40% depending on the phase of study execution.

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