Talent.com
Associate Manager, Site Start Up

Associate Manager, Site Start Up

South Dakota StaffingPierre, SD, US
1 day ago
Job type
  • Full-time
Job description

Site Start Up Opportunity

Parexel FSP has an exciting opportunity in Site Start Up! The Associate Manager, Site Start Up will have responsibilities for the creation and management of Site information within the CTMS system, including but not limited to Institution, relevant Personnel and related tasks / activities / deliverables associated with tracking Site Activation. Serves as the primary contact for creation and management of the Investigator and Institution Global Directory. Will play a leading role in ensuring the assembly and distribution of Site Administrative Binders to investigator sites at the time of site initiation / activation.

Job Duties :

  • Investigator / Institution Global Directory

Captures relevant information to create investigator / institution entities within the CTMS system to then enable site association with a clinical trial; routinely reconciles unique identifiers to ensure adherence to Sponsor requirements in addition to the alignment of industry / CRO related Identifiers

  • Gathers, tracks and reports on the status of Site Creation and Site Selection to ensure that all required study identifiers have been assigned and communicated as needed to promote alignment across standalone systems and repositories
  • May track the receipt of site generated documents (completed / signed forms, etc.) for the purposes of achieving Site Activation status for all identified and selected investigator sites
  • Assesses legibility / reproducibility and integrity / fidelity of documentation and ensures compliance to ICH / GCP and Sponsor requirements regarding Essential Documents
  • Enables the tracking of Site Initiation and Activation status for all selected investigator sites and may register key essential documents into the Trial Master File; Captures relevant study, country and site level information and milestones within the CTMS system
  • May track Site Training Documentation to ensure that Investigator site staff are appropriately trained on GCP / ICH guidelines, patient data capture requirements, Safety Letter distribution and other protocol specific requirements that may be defined by the clinical study team
  • Supports the identification of Investigator Meeting attendees (Site staff and Clinical Study team members) and ensures attendance
  • Enables tracking of Site Activation status for all selected investigator sites and may register key essential documents into the Trial Master File
  • Job Requirements

  • Working knowledge of the clinical drug development process, ICH / GCP and regulatory guidelines / directives
  • Demonstrates ability to prioritize and manage multiple projects simultaneously
  • Demonstrates effective problem solving and decision-making skills
  • Interpersonal, collaboration and stakeholder management skills, Good communication (written / verbal)
  • Highly organized, detail oriented
  • Ability to synthesize information and demonstrate strategic thinking
  • Self-motivated, flexible, able to follow through in a fast-paced environment, ability to meet deadlines under pressure
  • Computer skills with competency in MS suite, CTMS, eTMF; Veeva a plus
  • Education Requirements Bachelor's degree and minimum 1-3 years of relevant / clinical essential document review experience.

    EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    Create a job alert for this search

    Site Manager • Pierre, SD, US

    Related jobs
    • Promoted
    Data Center Site Selection Manager

    Data Center Site Selection Manager

    South Dakota StaffingPierre, SD, US
    Full-time
    Data Center Site Selection Manager.Meta designs, builds, leases, and operates the most leading-edge and efficient data centers in the world. Locating, developing and managing this data center infras...Show moreLast updated: 9 days ago
    • Promoted
    Center Manager in Training - Relocation Required

    Center Manager in Training - Relocation Required

    South Dakota StaffingPierre, SD, US
    Full-time
    Senior Operations Management Trainee (Senior OMT).Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we...Show moreLast updated: 26 days ago
    • Promoted
    Senior Director Colocation Infrastructure Construction Delivery-Data Centers

    Senior Director Colocation Infrastructure Construction Delivery-Data Centers

    South Dakota StaffingPierre, SD, US
    Full-time
    Senior Director of Colocation Infrastructure Construction Delivery.The Data Center Infrastructure Construction team at Oracle Cloud Infrastructure is a dynamic group of professionals dedicated to d...Show moreLast updated: 26 days ago
    • Promoted
    Pre-Construction Manager

    Pre-Construction Manager

    South Dakota StaffingPierre, SD, US
    Full-time
    Job Opportunity At Meta Platforms, Inc.Meta), formerly known as Facebook Inc.When Facebook launched in 2004, it changed the way people connect. Apps and services like Messenger, Instagram, and Whats...Show moreLast updated: 9 days ago
    • Promoted
    Senior Manager, Data Center Construction

    Senior Manager, Data Center Construction

    South Dakota StaffingPierre, SD, US
    Full-time
    Data Center Infrastructure Construction Team Role.The Data Center Infrastructure Construction team at Oracle Cloud Infrastructure is a dynamic group of professionals dedicated to delivering state-o...Show moreLast updated: 26 days ago
    • Promoted
    Director of Data Center Construction

    Director of Data Center Construction

    South Dakota StaffingPierre, SD, US
    Full-time
    Director Of Data Center Construction.As the Director of Data Center Construction you will be at the forefront of shaping the future of our data infrastructure. Your leadership will be pivotal in dri...Show moreLast updated: 26 days ago
    • Promoted
    Senior Data Center Construction Manager

    Senior Data Center Construction Manager

    South Dakota StaffingPierre, SD, US
    Full-time
    Senior Data Center Construction Manager.The Data Center Infrastructure Construction team at Oracle Cloud Infrastructure is a dynamic group of professionals dedicated to delivering state-of-the-art ...Show moreLast updated: 26 days ago
    • Promoted
    Product Operations Associate

    Product Operations Associate

    South Dakota StaffingPierre, SD, US
    Full-time
    ETS is a global education and talent solutions organization enabling lifelong learners worldwide to be future-ready.For more than 75 years, we've been advancing the science of measurement to build ...Show moreLast updated: 23 days ago
    • Promoted
    • New!
    Senior Manager, Product Management (Enterprise Website) - Capital One Software (Remote)

    Senior Manager, Product Management (Enterprise Website) - Capital One Software (Remote)

    Capital OnePierre, SD, United States
    Remote
    Full-time +1
    Senior Manager, Product Management (Enterprise Website) - Capital One Software (Remote).Ever since our first credit card customer in 1994, Capital One has recognized that technology and data can en...Show moreLast updated: 2 hours ago
    • Promoted
    Associate, Advisory Business Development

    Associate, Advisory Business Development

    wmPierre, SD, United States
    Full-time
    Primarily Houston-based hybrid role (Mon-Thurs in-office, Fri remote).Remote applicants from other states may be considered. WM Advisory Services is seeking a detail-oriented, customer service drive...Show moreLast updated: 6 days ago
    • Promoted
    Construction Manager, Leased

    Construction Manager, Leased

    South Dakota StaffingPierre, SD, US
    Full-time
    Meta is seeking an experienced Construction Manager to join our Data Center Engineering & Construction Team.Our data centers are the foundation upon which our rapidly scaling infrastructure efficie...Show moreLast updated: 26 days ago
    • Promoted
    Customer Resolution Associate - Remote

    Customer Resolution Associate - Remote

    South Dakota StaffingPierre, SD, US
    Remote
    Full-time
    Customer Resolution Associate - Remote.At Prime Therapeutics (Prime), we are a different kind of PBM, with a purpose beyond profits and a unique ability to connect care for those we serve.Looking f...Show moreLast updated: 1 day ago
    • Promoted
    Site Selection Manager

    Site Selection Manager

    South Dakota StaffingPierre, SD, US
    Full-time
    This role will be responsible for performing global analytics and conducting market research in targeted metros and regions, developing site selection opportunities, determining market rates, negot...Show moreLast updated: 26 days ago
    Commercial Lines Account Manager - Construction, Contractors (Remote Opportunity)

    Commercial Lines Account Manager - Construction, Contractors (Remote Opportunity)

    Insurance Office of AmericaPierre, SD, US
    Full-time
    Title : Account Manager - Commercial Lines.Eastern or Central Time Zone candidates).General, Construction, Contractors .Please note : If this position is posted as either fully remote and / or hybrid, ...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Sr. Manager, Product Management - Capital One Software (Remote)

    Sr. Manager, Product Management - Capital One Software (Remote)

    Capital OnePierre, SD, United States
    Remote
    Full-time +1
    Manager, Product Management - Capital One Software (Remote).Product Management at Capital One is a booming, vibrant craft that requires reimagining the status quo, finding value creation opportunit...Show moreLast updated: less than 1 hour ago
    • Promoted
    Business Manager, Shopping (Remote-Eligible)

    Business Manager, Shopping (Remote-Eligible)

    South Dakota StaffingPierre, SD, US
    Remote
    Full-time +1
    This is your opportunity to join Capital One's fast-growing consumer app : Capital One Shopping.Within Capital One, the Shopping team is working on a new consumer product that seeks to change the wa...Show moreLast updated: 1 day ago
    • Promoted
    Base Ecosystem Fund Lead

    Base Ecosystem Fund Lead

    South Dakota StaffingPierre, SD, US
    Full-time
    Base is planning to bring a million developers and a billion users onchain.We need your help to make that happen.Base is planning to bring a million developers and a billion users onchain.We need y...Show moreLast updated: 15 days ago
    • Promoted
    • New!
    Agronomy Sales Representative

    Agronomy Sales Representative

    CHS IncOnida, SD, United States
    Full-time
    United States that provides grain, food and energy resources to businesses and consumers around the world.We serve agriculture customers and consumers across the United States and around the world....Show moreLast updated: 11 hours ago