SMO Manager

Posted Yesterday
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Almaty
Senior level
Pharmaceutical
The Role
The SMO Manager will coordinate clinical trials, serve as the communication linchpin between sponsors and sites, manage patient enrollment tracking, maintain study records, ensure compliance with regulations, and promote Milestone One's offerings to potential clients. This role is pivotal for successfully driving clinical studies forward.
Summary Generated by Built In

Company Description

Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery.

    Job Description

    We're looking for experienced clinical trials professional to coordinate clinical trials on site and support our Business Development team in building and expanding the network of clients.

    In this role, you will:

    • Act as the main line of communication between the Sponsor or CRO and the site.
    • Ensure response to feasibility questions are provided in due time.
    • Assist in scheduling and preparation for all types of monitoring visits at the medical institution/research center.
    • Be present and available to respond to monitors during all types of monitoring visits conducted at the medical institution.
    • Track patient enrollment and actively support the medical site and CRO/Sponsor team in meeting project timelines and enrollment goals.
    • Maintain study specific and general tracking of documents at the site level.
    • Accurate and timely data entry into study specific EDC systems and timely resolution of data clarification queries issued for the site.
    • Timely report and follow up on Reportable Adverse Events and Protocol Deviations.
    • Proper handling, accountability and reconciliation of investigational products and clinical supplies.
    • Collect, handle and maintain all site-specific regulatory documents as needed.
    • Facilitate and support the contract and budget negotiations at the site level.
    • Support Investigator and Site payments and processes as needed.
    • Schedule and/or perform study procedures as per study requirements and delegation of responsibilities.
    • Prepare for and participate in onsite study audits or regulatory agency inspections.
    • Build and sustain long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions).
    • Support Site Development Manager with active promotion of Milestone One brand by acquiring new clinics and building a site network.
    • Conduct research on potential clients to build extended network.
    • Set up meetings with potential clients to present MO1 business opportunities and benefits of cooperation with Milestone One

    Qualifications

    • Education: College or university degree, life science is a plus.
      Experience: Minimum 5 years of experience in clinical environment as a CRA or study coordinator; experience as a medical representative dealing with medical institutions and physicians will be an advantage.


      Knowledge and skills:

    • Fluent use of English and local language
    • Proficiency in MS Office
    • Excellent communication and presentation skills
    • Excellent sales skills
    • Effective problem solving and result oriented
    • Ability to work in a team
    • Valid category B driver’s license

    Additional Information

    If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you.

    The Company
    HQ: Zug
    1,939 Employees
    On-site Workplace
    Year Founded: 1995

    What We Do

    PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.

    PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.

    PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.

    PSI’s reputation is that of a 'no-nonsense'​ CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.

    http://www.psi-cro.com

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