MANAGER, CLINICAL TRIALS

SPAULDING CLINICAL RESEARCH LLC•West Bend, WI

3d•$110,000 - $120,000

About The Position

The Manager, Clinical Trials (MCT) works under the direction and guidance of the Site Director and provides oversight to the Senior Study Managers, Study Managers (SMs), Associate Study Managers, Screening Coordinators and Regulatory Coordinators to perform duties as directed to support the quality completion of projects. The Manager, Clinical Trials, participates during all phases of the project process under the guidance of the Site Director to support other team members, provide guidance and training as needed, and to drive projects to successful completion. The MCT reports to the Site Director or designee. Essential Duties and Responsibilities: The MCT is expected to know, understand, and perform the responsibilities of the roles under their purview. In addition, the MCT’s main responsibilities will be: Supervises the daily work, as well as career management of the Clinical Trials Office staff including Senior Study Managers (Sr SMs), Study Managers (SMs), Associate Study Managers Study Managers (ASMs), Screening Coordinators and Regulatory Coordinators. Oversight of staff to ensure adherence to SOPs, Work Instructions, Good Clinical Practice (GCP), Good Documentation Practice (GDP), FDA Regulations and clinical study protocols. Responsible for clinical trial project cost management and budget review/adherence, as directed by management. Work closely with business development to provide protocol feedback/suggestions to ensure smooth service delivery within the Spaulding service model Provide mentoring and guidance to departmental staff Creates study management tools, processes, templates, and checklists and implements them throughout the department with very little oversight, to accomplish process improvement Throughout the study, ensures that all study activities are executed per the study protocol, regulatory guidelines, and operational/project plan. Demonstrated excellent planning, organization, and time management skills Proven ability to work creatively and analytically in a problem-solving environment Proactive contract scope management Demonstrated detailed knowledge of EMEA and FDA regulatory requirements Ability to provide input into SOP, WI, and CAPA documents Demonstrated presentation skills Reviews Investigational Drug Brochures, Protocols, Case Report Forms (CRFs), and informed consent forms for a thorough understanding of the study drug and procedures. Keeps abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines, state and national laws and ethical standards. Supports the development and management of project-specific Essential Documents. This includes preparation, tracking, documented quality control and quality assurance, then maintenance and final disposition for the TMF. Oversight of study management team with clinical support for data management (Biometrics) by resolving any data queries and clarifying data queries as requested and by timeline. Monitors clinical conduct to ensure adherence to protocol. May attend weekly teleconferences, periodically with Sponsor and Project Manager from startup to database lock if additional support is needed by Clinical Trials team Conducts a close-out inventory of clinical supplies, materials, pharmacy supplies, and coordinates the return of unused materials per Sponsor instruction. Ensure departmental compliance with regulatory requirements Assists Site Director with review and update of departmental SOPs Works collaboratively with Clinical Operations Manager to make recommendations for how to run complex study procedures such as IV dosing Participates in quality assurance of clinical research studies and initiates the need for same as it impacts on clinical practice. Provides study performance metrics as requested and update Study Summary file with project specific information. Responsible for updating current processes and contributing to new processes in order to streamline activities. This includes providing training plans to ensure gained knowledge and compliance. Provides timely and accurate status reports regarding project milestones and deliverables to Site Director and Associate Director of Project Management Supports Risk Mitigation strategies as provided by Sr. SMs, SMs and ASMs Provide prompt and thorough review (with appropriate feedback) on all study issues and escalations from Sr. SMs, SMs, ASMs, and Floor Staff Is present for clients (Sponsors), as requested and be available for site visits, teleconferences, and able to provide tours, if required. Willing and able to provide excellent customer service for all sponsors, their representatives, CRAs, etc. Provide protocol and associated document review to support business development for requests for proposals are provided Ensure customer satisfaction and repeat business. Provide onsite leadership for project team by building and motivating team members to meet project goals, adhering to their responsibilities and project milestones. Reviews study allocation/workload of Clinical Trials team members and appropriately forecasts departmental resourcing needs The Statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.

Requirements

Ability to read, write, and interpret the English language.
Demonstrated proficiency in protocol design, logistics, and implementation
Demonstrated ability to lead by example and to encourage team members to seek solutions
Excellent planning, organizational, and time management skills
Demonstrates strong analytical, problem solving skills
Excellent written and verbal communication skills
Strong attention to detail
Self-motivated, decisive, with the ability to adapt to change and competing demands
Proven ability to work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation and excellence.
Must be results oriented, multi-tasking, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines.
Good computer skills; inclination to adopt technology to maximize efficiency
Bachelor’s Degree in Life Sciences, Healthcare Management, Allied Health or related field, required.
Minimum of five years’ experience in Phase 1 clinical research and five years’ experience as Study Manager/Clinical Study Coordinator
At least 3 years’ experience in leadership/management
Demonstrated "Good Clinical Practices" and regulatory knowledge (ICH-GCP)

Responsibilities

Supervises the daily work, as well as career management of the Clinical Trials Office staff including Senior Study Managers (Sr SMs), Study Managers (SMs), Associate Study Managers Study Managers (ASMs), Screening Coordinators and Regulatory Coordinators.
Oversight of staff to ensure adherence to SOPs, Work Instructions, Good Clinical Practice (GCP), Good Documentation Practice (GDP), FDA Regulations and clinical study protocols.
Responsible for clinical trial project cost management and budget review/adherence, as directed by management.
Work closely with business development to provide protocol feedback/suggestions to ensure smooth service delivery within the Spaulding service model
Provide mentoring and guidance to departmental staff
Creates study management tools, processes, templates, and checklists and implements them throughout the department with very little oversight, to accomplish process improvement
Throughout the study, ensures that all study activities are executed per the study protocol, regulatory guidelines, and operational/project plan.
Reviews Investigational Drug Brochures, Protocols, Case Report Forms (CRFs), and informed consent forms for a thorough understanding of the study drug and procedures.
Keeps abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines, state and national laws and ethical standards.
Supports the development and management of project-specific Essential Documents. This includes preparation, tracking, documented quality control and quality assurance, then maintenance and final disposition for the TMF.
Oversight of study management team with clinical support for data management (Biometrics) by resolving any data queries and clarifying data queries as requested and by timeline.
Monitors clinical conduct to ensure adherence to protocol.
May attend weekly teleconferences, periodically with Sponsor and Project Manager from startup to database lock if additional support is needed by Clinical Trials team
Conducts a close-out inventory of clinical supplies, materials, pharmacy supplies, and coordinates the return of unused materials per Sponsor instruction.
Ensure departmental compliance with regulatory requirements
Assists Site Director with review and update of departmental SOPs
Works collaboratively with Clinical Operations Manager to make recommendations for how to run complex study procedures such as IV dosing
Participates in quality assurance of clinical research studies and initiates the need for same as it impacts on clinical practice.
Provides study performance metrics as requested and update Study Summary file with project specific information.
Responsible for updating current processes and contributing to new processes in order to streamline activities. This includes providing training plans to ensure gained knowledge and compliance.
Provides timely and accurate status reports regarding project milestones and deliverables to Site Director and Associate Director of Project Management
Supports Risk Mitigation strategies as provided by Sr. SMs, SMs and ASMs
Provide prompt and thorough review (with appropriate feedback) on all study issues and escalations from Sr. SMs, SMs, ASMs, and Floor Staff
Is present for clients (Sponsors), as requested and be available for site visits, teleconferences, and able to provide tours, if required.
Willing and able to provide excellent customer service for all sponsors, their representatives, CRAs, etc.
Provide protocol and associated document review to support business development for requests for proposals are provided
Ensure customer satisfaction and repeat business.
Provide onsite leadership for project team by building and motivating team members to meet project goals, adhering to their responsibilities and project milestones.
Reviews study allocation/workload of Clinical Trials team members and appropriately forecasts departmental resourcing needs