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    Positions


    Project Manager

    Position Overview: This position is responsible for managing and successfully completing clinical research projects.  The Project Manager becomes involved during the later phases of client marketing, and develops the project budget and the Project Plan.  The Project Manager also participates in protocol development and study-specific systems design.  The Project Manager establishes and monitors all project activities for adherence to plan and budget and becomes the primary contact with the client for that project.  The Project Manager is responsible for meeting the client’s goals and timelines within budget and with high quality.  Changes to the scope of a project must be reviewed and approved by the COO, prior to any commitment to the client.

    The PROJECT MANAGER participates in Team Meetings and attends mandatory all-staff meetings.  S/he will comply with Pharmatech SOPs and all federal regulatory guidelines for Good Clinical Practice.

    Essential Duties and Responsibilities:                                           

    1. Participate as a member of the project proposal team to assist in preparing project budgets and proposals.
    2. Develop a detailed Project Plan to meet the objectives of the project, objectives should include: contract requirements, client expectations, quality, enrollment goals, costs, time and profit. This plan should be stored on the Pharmatech computer network and available to both internal and external authorized users
    3. As required, collaborate with clients and investigators to develop protocols, data collection methods, study binders and investigative site materials, drug distribution and accounting methods, and patient safety reporting systems.
    4. Manage the project to achieve the deliverables of the project contract and the Project Plan, as follows:
      1. Develop enrollment tools for each project.
      2. Act as the primary contact for the client and the Investigator Sponsor and secondary contact for investigators and site personnel, and provide effective communication among all parties involved in the project and with Pharmatech senior management.
      3. Submit for approval all project purchases and expenses.
      4. Collaborate with clients and investigative sites in development of patient recruitment plan; monitor investigative sites and ensure enrollment quotas and timelines.
      5. Ensure monitor and/or study coordinator performance and data quality.
      6. Ensure the efficient and timely transfer and storage of all data documents.
      7. Ensure competent project file management.
      8. Manage the process for granting protocol waivers/violations/deviations.
    5. Coordinate regular telephone and/or face-to-face meetings with the project team and with the client team to discuss project status, problems, teamwork, or new plans.
    6. Address and resolve project questions and problems as needed; alert the COO of any problems that could impact the success of the project.
    7. Provide oversight of project teams to ensure that the project is completed within compliance of all regulatory bodies, client and Pharmatech SOPs, and the project contract requirements.
    8. Provide project status reports as requested by the client and Pharmatech senior management. Participate in conducting periodic performance reviews of project team members and post-project evaluations, and provide related reports.
    9. Act as a marketing agent in conjunction with the Pharmatech Business Development Team for future research projects with the customer, provide information for inclusion in RFPs, and attend Bid Defense Meetings as required.
    10. Participate in investigator network development, in cooperation with clients and the Pharmatech Business Development Team.
    11. As requested, provide Project Payables and Receivables projections to Accounting.
    12. Perform such other tasks as requested by Pharmatech senior management.

    Position Qualifications:

    • The incumbent must be able to work in and manage a team environment.
    • As such, a Project Manager must demonstrate leadership, the ability to listen to and develop personnel, resolve routine project problems, and have an understanding of standard business practices.
    • Clear written and verbal communication skills and the ability to draft business correspondence and develop budgets and detailed, computerized project plans are mandatory.
    • S/he must be able to coordinate and track multiple activities, meet precise deadlines with specific budgets, and identify and communicate to his/her supervisor problem areas before they negatively impact project outcomes.
    • A high degree of computer literacy is required.  Familiarity with MS Word, MS Excel, MS Access and basic email will be necessary.  Experience with MS Project a plus.

    Project Manager Associate

    Position Overview: This position is responsible for providing regulatory and administrative support to the assigned Pharmatech Project and Site Management Teams. The incumbent will provide support for project administrative tasks, mass mailings, document management, subject recruitment campaigns, travel arrangement, meeting coordination and special projects. This position is also responsible for preparing accurate, timely regulatory submissions of core project documents for clinical research studies and for monitoring and submitting changes of any core project documents to the appropriate persons, the Institutional Review Boards (IRBs) and the pharmaceutical sponsor companies or CROs. This position participates in Team Meetings and attends all-staff meetings.

    Essential Duties and Responsibilities:

    1. Provide project support as required, including:
      1. Correspondence, expense reports, schedule appointments and meetings
      2. Prepare meeting agendas; take, prepare and distribute minutes
      3. Retrieve and send email
      4. Arrange for conference calls involving more than three parties
      5. Meeting coordination
      6. Prepare meeting materials and presentations including MS PowerPoint
      7. Document management including photocopying, disbursement and filing
      8. Perform data entry to MS Access databases
      9. Assemble Site Binders, if required
      10. Create and assemble Project File Binders
      11. Assist with bulk mail/email/fax projects
      12. Assist with development of source documents and enrollment tools
      13. Assist with preparation of reports for Grant Management
      14. Assist with resolution of Data Queries and Data Management reports
      15. Filing and other tasks as directed
    2. Provide Regulatory document preparation, submissions, updates as required:
      1. Interact with Clinical Site to ensure Pharmatech receives all necessary regulatory documentation for IRB submittal, including but not limited to:  1572, financial disclosures,  contracts, CV’s, medical licenses, lab certifications and values, and any updates to these documents
      2. Prepare necessary regulatory documents based on investigational requirements and submit to the IRB and Sponsor/CRO as necessary
      3. Initiate any required action following IRB review, if any stipulations are noted with the protocol or informed consent
      4. Follow IRB approval with timely preparation of Regulatory Binders
      5. Ensure changes to regulatory documents are submitted to the IRB in a timely manner
      6. Submit documents to FDA as needed, and ensure any necessary follow-up
      7. Submit study and site project documents to Sponsor/CRO (when required)
        Interact with FDA and/or IRB as needed to achieve project regulatory goals and objectives
      8. Responsible for creation and final filing of Regulatory Binders housed in Central Files
      9. Maintain up-to-date and accurate regulatory records for each project
        Administer project close-out process
      10. Prepare correspondence as needed and as requested by Pharmatech management
      11. Assist in resolving questions/problems as needed, and as requested by Pharmatech management
    3. Demonstrates a solid understanding of the protocol, project and timelines for assigned studies.

    Position Qualifications:
    • Work with limited supervision and develop processes to produce results
    • Coordinate and track multiple activities and meet precise deadlines
    • Draft and edit business correspondence
    • Work in a team environment and participate as such
    • Excellent interpersonal skills
    • Clear written and verbal communication skills are mandatory
    • Attention to detail, time management and organizational skills
    • Computer proficiency in MS Word, MS Excel, MS Access, MS PowerPoint and MS Outlook
    • Standard office equipment, such as a copier, facsimile machine, personal computer, shredder and adding machine.

    Project Assistant

    Position Overview: This position is responsible for providing regulatory and administrative support to the assigned Pharmatech Project and Site Management Teams.  The incumbent will provide support for project administrative tasks, mass mailings, document management, subject recruitment campaigns, travel arrangement, meeting coordination and special projects.  This position is also responsible for preparing accurate, timely regulatory submissions of core project documents for clinical research studies and for monitoring and submitting changes of any core project documents to the appropriate persons, the Institutional Review Boards (IRBs) and the pharmaceutical sponsor companies or CROs.  This position participates in Team Meetings and attends all-staff meetings.

    Essential Duties and Responsibilities:                                           

    1. Provide project support as required, including:
      1. Correspondence, expense reports, schedule appointments and meetings
      2. Prepare meeting agendas; take, prepare and distribute minutes
      3. Retrieve and send email
      4. Arrange for conference calls involving more than three parties
      5. Meeting coordination
      6. Prepare meeting materials and presentations including MS PowerPoint
      7. Document management including photocopying, disbursement and filing
      8. Perform data entry to MS Access databases
      9. Assemble Site Binders, if required
      10. Create and assemble Project File Binders
      11. Assist with bulk mail/email/fax projects
      12. Assist with development of source documents and enrollment tools
      13. Assist with preparation of reports for Grant Management
      14. Assist with resolution of Data Queries and Data Management reports
      15. Filing and other tasks as directed
    2. May provide Regulatory document preparation, submissions, updates as required, under the direction of Project Manager or Director, Clinical Operations:
      1. Assist with interactions with Clinical Site to ensure Pharmatech receives all necessary regulatory documentation for IRB submittal, including but not limited to:  1572, financial disclosures,  contracts, CV’s, medical licenses, lab certifications and values, and any updates to these documents
      2. Assist with the preparation of necessary regulatory documents based on investigational requirements and submit to the IRB and Sponsor/CRO as necessary
      3. Assist with any required action following IRB review, if any stipulations are noted with the protocol or informed consent
      4. Follow IRB approval with timely preparation of Regulatory Binders, under direction of Project Manager
      5. Assist with ensuring changes to regulatory documents are submitted to the IRB in a timely manner
      6. Assist with submission of documents to FDA as needed, and ensure any necessary follow-up
      7. Assist with the submission of study and site project documents to Sponsor/CRO (when required)
      8. Assist with interactions with FDA and/or IRB as needed to achieve project regulatory goals and objectives
      9. Assist with the creation and final filing of Regulatory Binders housed in Central Files
      10. Maintain up-to-date and accurate regulatory records for each project
      11. Assist with the administering of project close-out process
      12. Prepare correspondence as needed and as requested by Pharmatech management
      13. Assist in resolving questions/problems as needed, and as requested by Pharmatech management

    Position Qualifications:

    • Work with limited supervision and develop processes to produce results
    • Coordinate and track multiple activities and meet precise deadlines
    • Draft and edit business correspondence
    • Work in a team environment and participate as such
    • Excellent interpersonal skills
    • Clear written and verbal communication skills are mandatory
    • Attention to detail, time management and organizational skills
    • Computer proficiency in MS Word, MS Excel, MS Access, MS PowerPoint and MS Outlook
    • Standard office equipment, such as a copier, facsimile machine, personal computer, shredder and adding machine.

     


    Contact

    Human Resources

     

    720-917-7476hr@pharmatech.com

    Disclaimers

    All requirements are subject to possible modification to reasonably accommodate individuals with disabilities.  Some requirements may exclude individuals if they pose a direct threat or significant risk to the health and safety of themselves or other employees.

    This position description in no way states or implies that these are the only duties to be performed by the employee occupying this position.  Employees will be required to follow any other job-related instructions and to perform other job related duties requested by their supervisor.

    Requirements are representative of minimum levels of knowledge, skills and/or abilities.  To perform this job successfully, the incumbent will possess the abilities or aptitudes to perform each duty proficiently.

    This document does not create an employment contract, implied or otherwise, and this position fully understands the “at-will” employment relationship between Pharmatech and its employees.