Sr Director, Clin Development (Medical Device Development Lifecycle Subject Matter Expert) at Syneos Health in Remote
Ensures the contracted services and expectations of a clinical study are carried out by the project team in accordance with the executed contract and the Customer's expectations. Oversees a group of projects to ensure objectives are met. Works in the role of an executive-level oversight on assigned project(s), which may range from single service studies to large full scope or multiple protocol projects. May perform the role of global project manager or program manager, including management of Medical Device & Diagnostic Development Programs (MD&DDP), as needed. Duties include primary liaison with Customers, Vendors, Senior Management and/or Investigative Sites. Line management responsibilities for other project management staff.
Essential Functions:
o Acts as a primary liaison between the Company and the Customer to ensure study launch, conduct and closeout according to the agreement. Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), and Good Clinical Practices (GCPs) to fulfill all federal and local regulations. o Serves as the team leader for the project team. Facilitates team building and communication. Acts as a liaison and facilitator between other operation departments for project related tasks and/or issues. Plans and negotiates resources with line management of functional areas. o Actively manages and mentors other Project Management staff (which may include:
Project Directors, Senior Project Managers, Project Managers and Project Specialists) in general team leadership skills, customer management skills, project management skills, internal processes, and for project specific tasks. May work with the Project Manager on the study start up tasks (as the study start up expert) of a project to ensure success of the overall project. o Manages projects ranging in size and complexity from single service studies to large full scope, multiple protocol projects, global projects and/or programs (including medical device & diagnostics development programs), with minimal interaction from supervisor. This includes management of resources, tasks, risk and quality. o Manages the executed contract and financial aspects of assigned projects/programs. Reviews and approves study budgets and expenses and ensures all study related contractual and budgeting issues are upheld and performed. Oversees and tracks site payment issues as required. Ensures customers are invoiced in a timely manner and follows up on receipt of payment. o Develops knowledge of current therapeutic environment and medical device & diagnostics development trends as needed. Facilitates team training in accordance with protocol and/or project requirements including therapeutic, protocol specific, and process training. May review protocol to ensure sponsor's objectives are met and are in line with their Medical Device & Diagnostics Development Program, as well as fulfilling FDA or other regulatory bodies' guidelines. o Reviews protocol, CRF and edit specifications for consistency within each document, and cross-checks these documents against each other. o Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports, and ensures adequate documentation of each communication. o Independently prepares information for internal review meetings. Presents prepared information at project review meetings. Reviews and approves information from project managers/directors for internal review meetings. o Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status, resourcing and tracking reports as well as functional area plans, to appropriate team members and senior management. o Oversees the regulatory document collection and submission process. o Serves as a Project Advisor to project teams regarding the operational and project management aspects of projects. o Assists in the negotiation and contracting process with outside vendors such as laboratories, printers, packaging, labeling and storage, and Interactive Voice Response System companies. o Networks to acquire new and/or repeat business. o Supports the Business Development Department by providing information on Company capabilities, patient populations, etc. Presents company capabilities as well as project management specific responsibilities at Customer proposal defense meetings. o Works with Business Development and the Proposal/Contracts groups to develop proposals for Customer requested opportunities. Works with this team to develop budgets and scope of work for the final contract. o Represents the Company at professional meetings or seminars. o May develop and refine project management processes. o Develops and/or reviews SOPs and WIs related to any area concerning project management. o Develops and refines processes which lead to greater efficiencies or competitive advantages over other companies. Qualifications Requirements:
o BA/BS in the life sciences, nursing degree, or equivalent education or experience; plus extensive clinical research experience in a contract research organization (CRO), medical device or diagnostics Company. o Must have experience actively managing clinical research projects across functional areas including supervision experience. o A thorough knowledge of FDA regulations, medical device and diagnostics development, clinical monitoring procedures and demonstrated proficiency with ICH guidelines. o Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail. o Ability to mentor and manage new staff, be flexible, to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment. o Possesses strong presentation, documentation and interpersonal skills as well as a team-oriented approach.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Essential Functions:
o Acts as a primary liaison between the Company and the Customer to ensure study launch, conduct and closeout according to the agreement. Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), and Good Clinical Practices (GCPs) to fulfill all federal and local regulations. o Serves as the team leader for the project team. Facilitates team building and communication. Acts as a liaison and facilitator between other operation departments for project related tasks and/or issues. Plans and negotiates resources with line management of functional areas. o Actively manages and mentors other Project Management staff (which may include:
Project Directors, Senior Project Managers, Project Managers and Project Specialists) in general team leadership skills, customer management skills, project management skills, internal processes, and for project specific tasks. May work with the Project Manager on the study start up tasks (as the study start up expert) of a project to ensure success of the overall project. o Manages projects ranging in size and complexity from single service studies to large full scope, multiple protocol projects, global projects and/or programs (including medical device & diagnostics development programs), with minimal interaction from supervisor. This includes management of resources, tasks, risk and quality. o Manages the executed contract and financial aspects of assigned projects/programs. Reviews and approves study budgets and expenses and ensures all study related contractual and budgeting issues are upheld and performed. Oversees and tracks site payment issues as required. Ensures customers are invoiced in a timely manner and follows up on receipt of payment. o Develops knowledge of current therapeutic environment and medical device & diagnostics development trends as needed. Facilitates team training in accordance with protocol and/or project requirements including therapeutic, protocol specific, and process training. May review protocol to ensure sponsor's objectives are met and are in line with their Medical Device & Diagnostics Development Program, as well as fulfilling FDA or other regulatory bodies' guidelines. o Reviews protocol, CRF and edit specifications for consistency within each document, and cross-checks these documents against each other. o Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports, and ensures adequate documentation of each communication. o Independently prepares information for internal review meetings. Presents prepared information at project review meetings. Reviews and approves information from project managers/directors for internal review meetings. o Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status, resourcing and tracking reports as well as functional area plans, to appropriate team members and senior management. o Oversees the regulatory document collection and submission process. o Serves as a Project Advisor to project teams regarding the operational and project management aspects of projects. o Assists in the negotiation and contracting process with outside vendors such as laboratories, printers, packaging, labeling and storage, and Interactive Voice Response System companies. o Networks to acquire new and/or repeat business. o Supports the Business Development Department by providing information on Company capabilities, patient populations, etc. Presents company capabilities as well as project management specific responsibilities at Customer proposal defense meetings. o Works with Business Development and the Proposal/Contracts groups to develop proposals for Customer requested opportunities. Works with this team to develop budgets and scope of work for the final contract. o Represents the Company at professional meetings or seminars. o May develop and refine project management processes. o Develops and/or reviews SOPs and WIs related to any area concerning project management. o Develops and refines processes which lead to greater efficiencies or competitive advantages over other companies. Qualifications Requirements:
o BA/BS in the life sciences, nursing degree, or equivalent education or experience; plus extensive clinical research experience in a contract research organization (CRO), medical device or diagnostics Company. o Must have experience actively managing clinical research projects across functional areas including supervision experience. o A thorough knowledge of FDA regulations, medical device and diagnostics development, clinical monitoring procedures and demonstrated proficiency with ICH guidelines. o Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail. o Ability to mentor and manage new staff, be flexible, to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment. o Possesses strong presentation, documentation and interpersonal skills as well as a team-oriented approach.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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