Pharm-Olam International

  • Head of Global Trial Master File Management, PSRM

    Job Locations US | US-NC-Raleigh-Durham | US-TX-Houston
    Job ID
    2018-1877
    Category
    Corporate
  • Overview

    About Pharm-Olam International:

     

    Pharm-Olam International is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

    Summary:

     

    Head of a team of clinical documentation specialist resources which contribute to the effective delivery of Pharm-Olam’s Trial Master file (TMF) requirements to the business globally. Provides expertise to the business for TMF and electronic TMF (eTMF) management, setup and manages the business processes for Pharm-Olam’s TMF/eTMF, setup best practices and processes to meet clients and regulatory requirements. Ensures key performance indicators are set globally for TMF and eTMF with systematic methodology to monitor status and manage actions plans to meet KPI expectations.  Provides leadership in strategic planning, business automation planning, and business process improvements related to clinical documentation and TMF/eTMF.

    Responsibilities

    Team Leadership

    • Leads by example in recognizing, exemplifying and adhering to Pharm-Olam’s Code of Conduct which sets forth guidance for day-to-day behaviour and decision making.
    • Recognize the importance of and create a culture of process improvement with a focus on streamlining processes adding value to our business and meeting client needs.
    • Builds an effective, highly-performing TMF/eTMF team (including centralized eTMF team) through influence, integration, and motivation.
    • Optimizes the team’s efficiency and effectiveness by focusing on accountability for performance and behavior in accordance with Pharm-Olam’s policies and applicable regulations.
    • Provides resources and opportunity for appropriate training, mentoring and other experiences for the TMF/eTMF Administration personnel.

    Logistics/Oversight

    • Working closely with TMF Managers and coordinate TMF provisioning, setup/maintenance and overall scheduling required to deliver a new study across the Pharm-Olam’s TMF portfolio.
    • Working closely with TMF Managers / Resources, coordinates close down of TMF projects for client delivery, to include the planning, execution, verification and closeout of activities.
    • Estimates costs across functional, technical and vendor resources to support TMF Management.
    • Develops policies and procedures to support the clinical TMF delivery management process.
    • Recommends improvements to enhance clinical TMF/ Clinical Document Management functionality.
    • Attends TMF technology conferences to increase product understanding and develop industry contacts.
    • Participates in needs assessment, TMF software design advisory board, implementation, support, and reporting.
    • Provides input to components of the development of end-user training materials and participates in training efforts.
    • Works closely with Department Heads and SMEs in the understanding of operational processes to support the delivery of technology to those groups (if required).
    • Applies high degree of understanding of clinical operation business processes to routine responsibilities and process/technology improvements.

    Quality/Audits

    • Provides comprehensive knowledge of regulatory requirements that impact the use of clinical TMF applications and business processes (e.g., GDPR, 21 CFR Part11, EU Annex 11, ICH GCP, Pharm-Olam SOPs, etc.)
    • Coordinates efforts to ensure compliance with regulatory requirements.
    • Monitors and provides advice concerning computer system validation efforts.
    • Attends and serves as head Clinical Documentation representative for client, regulatory agency or internal audits.
    • Works with key stakeholders in the development of quality and performance metrics across clinical document management portfolio.
    • Collaborates with Compliance and Quality Assurance department where necessary.

    Resourcing

    • Determines level of functional effort required to setup and maintain TMF studies across application portfolio and works with TMF Managers to ensure the appropriate assignment of resources to study.

    Project/Study Oversight Participation

    • Attends Handover Meetings
    • Attends Project Review Meetings
    • Provides quality/ performance metrics to support Executive Management Meetings

    Business Development

    • Participates in RFP response/proposal development as it pertains to the use of Pharm-Olam’s clinical documentation portfolio.
    • Participates where required in Bid Defence meetings to present, in person, on the capabilities of the TMF applications portfolio.
    • Develops sales materials (e.g., slide decks, product briefs, white papers) to support the Business Development and Account Development process.

    Client Relations

    • Serves as primary contact for client needs and concerns as it relates to the clinical documentation portfolio to include: reporting, TMF service enablement, and logistics based on client’s requirements.
    • Works with Pharm-Olam Marketing & Communications department and Program Management Office to provide communication to clients with regard to process changes, business advancement plans.

    Working Relationship:

     

    • Reports to the Head of Portfolio Sourcing and Relationship Management, or designee.
    • Collaborates with Project Management, Clinical Operations staff, QA and other Pharm-Olam departments.
    • Liaises with clients/sponsors.
    • Supervises, develop skills and knowledge of assigned direct reports and/or more senior team members in accordance with Pharm-Olam SOPs/WIs/Policies, clients data protection requirements.
    • Provides regular key performance indicator reports and feedback to executive management including measurable goals and objective target statements.
    • Liaises with vendor(s) for TMF technology delivery.

    Qualifications

    • Bachelor’s degree, preferably in Business Management/Biological Science or equivalent on job work experience required.
    • Must have advanced eTMF software(s) and clinical operation knowledge in addition to the ability to supervise staff.
    • Strong Computer Skills a must.
    • Has experience and expertise with TMF delivery / project management.
    • Proficiency in MS Office and internet applications required.
    • Minimum of 10 years of experience in the life sciences industry preferred.
    • Prior experience working with or managing a clinical documentation team preferred.
    • Ability to travel 30% or as needed
    • Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred.
    • Must have superior attention to detail and excellent oral and written communication skills.
    • Must have the ability to work under pressure with multiple competing priorities.
    • Must have strong time management, and organizational skills.
    • Prioritizing workload to the changing needs of the day to day business is also a critical skill.
    • Knowledge of departmental change management procedures and standards are required.
    • Ability to work in strict compliance with all procedures, rules and regulations.
    • Maintain strict confidentiality of sensitive data, records, files, conversations, etc.

     

    For Consideration

     

    Please apply online at www.pharm-olam.com/careers

     

    Pharm-Olam International, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

    This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

     

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed