Clinical Program Manager II Remote Apply
For further information please contact our Talent Specialist
Pratichi| 630 847 0267
Meghna | 224 369 4230
Sudhanshu | 224 303 4498
Swathi | 224-507-1280
Title : Clinical Program Manager II (Remote)
Location : San Diego,CA
Duration : 12 months
Description:
The Staff Clinical Program Manager will provide strategic leadership and direction to Clinical Affairs in leading, planning and execution of complex clinical strategies with focus on at least one key business area which will require development of subject matter expertise in one/many specific business strategies.
A successful leader in this role will understand and translate business strategies into designing and execution of clinical studies to support broader objectives. This is a strategic role who also understands how to tactically execute clinical studies within Clinical Affairs to ensure success.
Essential Duties and Responsibilities:
Oversees multiple interconnected, complex projects, coordinates departmental or cross-functional teams, and focused on delivering new or upgrading existing products.
Drive the full spectrum of the clinical execution from the design phase to close-out, while collaborating closely with internal and external subject matter experts.
Interface with representatives from key functional groups including Executive Management, Product Development/R&D, Regulatory Affairs, Quality Assurance, and Operations as well as Clinical Research Organizations (CROs) to set operational direction and strategy for clinical study activities.
Work in collaboration with functional leaders to design/implement strategies and track project plans related to trial design.
May serve as a member of core team(s) providing strategic direction to study teams to meet goals and timelines.
Manage strategic study operations including study sites and tracking systems for regulatory submissions, CRO KPIs, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, performance metrics, data flow, etc.
Coordinate and prioritize activities amongst trials/establish study milestones to ensure timelines are met.
Provide direction and supervise (PM) team in execution of studies.
Recommends and implements innovative ideas to increase efficiency and quality of study management activities.
Consult trial teams when enrollment is below projection; provide mitigation planning, enrollment data analysis and scenario planning.
Recommends selection of Contract Research Organizations (CROs) through competitive bid process and other necessary vendors to support study requirements.
Provide oversight and execution of CRO study deliverables to ensure that objectives are met.
Successfully drive trial milestones to timelines, project plans while maintaining study budgets.
Facilitates collaborative environment through team building activities, mentorship and leadership.
Tracking and reporting of study metrics.
Identify and mitigate risks to study implementation, enrollment, conduct, compliance, and completion.
Manages all aspects of Clinical Study execution, including planning, start-up, enrollment, follow-up and close-out.
Required Qualifications:
Bachelor's Degree in biological sciences or related medical/scientific field and at least 8 years' related experience, at least 5 years of which involve leading clinical studies; or, a Master's degree with minimum 5 years' equivalent industry experience; or a PhD and at least 2-4 years of equivalent industry experience.
Strong regulatory knowledge, including Good Clinical Practices (GCPs).
Exceptional organizational skills and ability to deal with competing priorities, strong reasoning and problem-solving ability.
Excellent communication (written and verbal) and presentation skills along with leadership qualities.
Experience with protocol and ICF development.
Strong organizational skills and ability to deal with competing priorities.
Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.
Ability to be independent, multitask and results-oriented with hands-on attitude in a fast-paced and energetic environment with experience in assembling a plan and executing on the details.
Willing to work in an extremely fast-paced environment with high attention to details and accuracy.
Proven successful experience managing outside CRO groups in Class II/III, preferably diabetes, device studies.
Data-driven decision-making mindset.
Strong interpersonal communication skills and ability to work effectively on cross-functional & global teams.
Must be highly collaborative and able to work in a team-based environment.
Strong organizational skills. Team building and team leadership skills.
Ability to manage conflict professionally, strong "can do" attitude.
Preferred Qualifications:
Working knowledge of Clinical Program Management methodologies, tool/metric development and risk management.
Understanding the intersectionality between designing/implementing clinical strategy to broader business objectives.
Broad operations experience, including experience in clinical study management, clinical data management and/or clinical site monitoring within the medical device industry.
Strong working knowledge or project management tools (MS Project, Smartsheet, Office Timeline Pro+, etc.)
Demonstrated success in developing clinical strategies and designing and conducting, clinical trials in support of medical devices in the US.
A track record of successful management of IDE trials in the US, for 510k and PMA products.
Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of clinical studies, as well as preparation of clinical documentation in support of regulatory submissions.
Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with medical professionals.
Analytical, strategic thinker with leadership ability and style that demonstrates professionalism and establishes respect.
Excellent organizational and project management skills with high sense of organization and attention to detail.
Experience in continuous glucose monitoring (CGM) is a plus.
A successful leader in this role will understand and translate business strategies into designing and execution of clinical studies to support broader objectives. This is a strategic role who also understands how to tactically execute clinical studies within Clinical Affairs to ensure success.
Essential Duties and Responsibilities:
Oversees multiple interconnected, complex projects, coordinates departmental or cross-functional teams, and focused on delivering new or upgrading existing products.
Drive the full spectrum of the clinical execution from the design phase to close-out, while collaborating closely with internal and external subject matter experts.
Interface with representatives from key functional groups including Executive Management, Product Development/R&D, Regulatory Affairs, Quality Assurance, and Operations as well as Clinical Research Organizations (CROs) to set operational direction and strategy for clinical study activities.
Work in collaboration with functional leaders to design/implement strategies and track project plans related to trial design.
May serve as a member of core team(s) providing strategic direction to study teams to meet goals and timelines.
Manage strategic study operations including study sites and tracking systems for regulatory submissions, CRO KPIs, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, performance metrics, data flow, etc.
Coordinate and prioritize activities amongst trials/establish study milestones to ensure timelines are met.
Provide direction and supervise (PM) team in execution of studies.
Recommends and implements innovative ideas to increase efficiency and quality of study management activities.
Consult trial teams when enrollment is below projection; provide mitigation planning, enrollment data analysis and scenario planning.
Recommends selection of Contract Research Organizations (CROs) through competitive bid process and other necessary vendors to support study requirements.
Provide oversight and execution of CRO study deliverables to ensure that objectives are met.
Successfully drive trial milestones to timelines, project plans while maintaining study budgets.
Facilitates collaborative environment through team building activities, mentorship and leadership.
Tracking and reporting of study metrics.
Identify and mitigate risks to study implementation, enrollment, conduct, compliance, and completion.
Manages all aspects of Clinical Study execution, including planning, start-up, enrollment, follow-up and close-out.
Required Qualifications:
Bachelor's Degree in biological sciences or related medical/scientific field and at least 8 years' related experience, at least 5 years of which involve leading clinical studies; or, a Master's degree with minimum 5 years' equivalent industry experience; or a PhD and at least 2-4 years of equivalent industry experience.
Strong regulatory knowledge, including Good Clinical Practices (GCPs).
Exceptional organizational skills and ability to deal with competing priorities, strong reasoning and problem-solving ability.
Excellent communication (written and verbal) and presentation skills along with leadership qualities.
Experience with protocol and ICF development.
Strong organizational skills and ability to deal with competing priorities.
Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.
Ability to be independent, multitask and results-oriented with hands-on attitude in a fast-paced and energetic environment with experience in assembling a plan and executing on the details.
Willing to work in an extremely fast-paced environment with high attention to details and accuracy.
Proven successful experience managing outside CRO groups in Class II/III, preferably diabetes, device studies.
Data-driven decision-making mindset.
Strong interpersonal communication skills and ability to work effectively on cross-functional & global teams.
Must be highly collaborative and able to work in a team-based environment.
Strong organizational skills. Team building and team leadership skills.
Ability to manage conflict professionally, strong "can do" attitude.
Preferred Qualifications:
Working knowledge of Clinical Program Management methodologies, tool/metric development and risk management.
Understanding the intersectionality between designing/implementing clinical strategy to broader business objectives.
Broad operations experience, including experience in clinical study management, clinical data management and/or clinical site monitoring within the medical device industry.
Strong working knowledge or project management tools (MS Project, Smartsheet, Office Timeline Pro+, etc.)
Demonstrated success in developing clinical strategies and designing and conducting, clinical trials in support of medical devices in the US.
A track record of successful management of IDE trials in the US, for 510k and PMA products.
Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of clinical studies, as well as preparation of clinical documentation in support of regulatory submissions.
Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with medical professionals.
Analytical, strategic thinker with leadership ability and style that demonstrates professionalism and establishes respect.
Excellent organizational and project management skills with high sense of organization and attention to detail.
Experience in continuous glucose monitoring (CGM) is a plus.
About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
