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Clinical Medical Affairs III
Ref No.: 17-03134
Location: Warsaw
Start Date / End Date: 06/01/2017 to 06/02/2018


PO on Behalf of Person (will need Ariba access): Jennifer Hoag
PO Owner Site Location: 700 Clientpaedic Dr, Warsaw, IN 46582
Time Card Approver: Jennifer Hoag
Department Name: Clinical

Work Location Site: Cincinnati, Ohio or Warsaw IN
Start Date: 6/1/2017
End Date: 6/2/2018
Hours/Schedule: Regular first shift

Job Title: Clinical Trial Manager (for Fieldglass, Clinical Medical Affairs III used)
Pre-ID Candidate or Recruiting: Recruiting
Please Forward Resume of Pre-ID Candidate: N/A
Smart Desk Approval #: Smart Desk Temp Staffing 595, attached

Detailed Job Description: Below and Attached
OVERALL RESPONSIBILITIES:
This individual will be responsible for clinical trial management within the Clinical R&D Operations CoE, as well as fostering strong, productive relationships with colleagues across the organization. Serves as the liaison with the Clinical R&D Franchise for projects under his/her responsibility.

POSITION DUTIES & RESPONSIBILITIES:
• Serve as a Clinical Trials Manager within the Clinical R&D Operations CoE group to execute company sponsored clinical trials for the Medical Device Franchises
• Manage all operational activities of assigned clinical trials/programs within the Clinical R&D Operations group
• Serves as a member of the clinical trial/study/program core team and may serve as the back-up liaison to the Clinical R&D Franchise and Clinical R&D BSDM for projects/trials/programs under his/her responsibility
• May serve as the primary contact for clinical trial sites
• Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed
• Manage all operational activities of assigned clinical studies within the Clinical R&D Operations group
• Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
• May be involved in other tasks to support Clinical R&D Operations and R&D Clinical Franchise as needed
• Plan, track and manage assigned projects budgets to ensure adherence to business plans
• Support the implementation of new clinical systems/processes, and provide support for publications, as needed.
• Interface and collaborate with site personnel, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
• Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
• Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency


People Leadership:
• Ensure that all Human Resource related activities, and decisions embody the Pharmaceutical Credo Values.
• Provide primary leadership within a clinical trial, ensuring that each team member has a well-defined set of activities and objectives specific to their role and responsibilities within the context of their business focus.
• Ensure efficient use of resources within the clinical trial/program to provide high quality deliverables.
• Ensure that outstanding performance is rewarded and consistently strives to improve the performance, reputation, and image of the R&D Clinical CoE.
• Manage and mentor Clinical Trial Leaders/Sr. Clinical Trial Leaders/Staff Clinical Trial Leaders, as applicable.
• Responsible for the training, performance management, and development of clinical staff.

Business Leadership:
• Accountable for quality, compliance with regulations and company procedures, resource requirement, timelines and budgets for assigned clinical projects, including those assigned to direct reports.
• May lead clinical trials and/or a program that may involve multiple trial managers/leaders and CROs (?500k USD annual investment).
• Act as an operational expert rotating to new projects to provide technical expertise and training in starting new studies.
• May support Senior CTM within a large or complex regulated clinical trial/program.
• Exhibit proficiency and act as a Subject Matter Expert in clinical trials involving complex design issues. May provide solutions and guidance on complex situations.
• May manage work performed by CROs.
• Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, cost-effective, and high quality execution of assigned clinical studies/programs, including those assigned to direct reports.
• May support clinical trial design and strategy.
• Reviews and provides feedback on protocols.
• Understand business value and balance overall business objectives and functional needs.

Functional and Technical Competencies:
• Requires knowledge of Good Clinical Practices
• Knowledge and application of regulations and standards applied in clinical areas/regions is required.
• Strong project management skills with ability to handle multiple projects
• Strong people management skills
• Demonstrated competencies in the following areas are required:
• Leadership in a professional and ethical manner
• Presentation skills and influencing of others
• Written and oral communication skills
• Advanced technical writing skills
• Advanced project management skills with ability to handle multiple projects

Leadership Competencies:
Strong leadership required in alignment with Pharmaceutical Leadership Imperatives:
• Connect - Develop collaborative relationships personally and within allocated team with key internal and external stakeholders, across the global CoE as well as the resources providers and vendors to create a strong and productive partnership.
• Shape - Through efficient use of resources shape the way clinical trial management is conducted and resources are utilized
• Lead - Through transparent leadership, ensure appropriate escalation of compliance issues.
• Deliver - Ensure all sponsored studies have appropriately trained clinical trial leaders assigned and oversee their activities and conduct own activities to ensure all deliverables are met on time, within budget and in compliance to SOPs and regulations.

• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
• Performs other related duties as required.

EDUCATION & EXPERIENCE REQUIREMENTS:
Education
• Masters or equivalent required. Preferably in Life Science, Nursing or Biological Science.
Experience
• 8 -10 years of relevant experience or equivalent required.
• Minimum of 2 years people management.
• Significant previous experience in clinical project leadership across multiple studies/programs required.
• Experience with budget planning, tracking and control required.
• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
• Clinical/medical background a plus.