Talent.com
Business Operations Manager Site Monitoring Strategy Training and Oversight

Business Operations Manager Site Monitoring Strategy Training and Oversight

Astellas PharmaNorthbrook, IL, US
4 days ago
Job type
  • Full-time
Job description

Business Operations Manager Site Monitoring Strategy Training and Oversight

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world.

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope :

This position is responsible for the execution of assigned responsibilities within the relevant Clinical Operations support function for both early and late-stage Clinical Operations.

Clinical Operational Excellence (COE) supports functions in scope for this position and may include :

  • Clinical Compliance
  • Site Monitoring and Management
  • Business Operations includes department performance management, metrics, enhancement, and departmental communication strategy & management
  • Process, Training & Development
  • Trial Master File
  • Clinical Operational Standards
  • Clinical Systems standards and management
  • Site Start Up and Activation
  • Country and Site Feasibility
  • Accountable for management of budgets, timelines, and workload

Reports to the Business Operations Lead, Clinical Operational Excellence or above. This position may provide oversight and direction to team members for deliverables and may provide direct supervision for contract team members.

Essential Job Responsibilities :

  • Manage and may lead the day-to-day operations within site monitoring and management function focusing on Clinical Site Manager training and oversight to ensure completion per established goals and objectives in compliance with applicable GCP / ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g. study teams) to support timely completion of both drug and non-drug program goals and objectives.
  • Manage and may lead functional and cross-functional internal teams.
  • Proactively identify and escalate issues that arise related to support functional deliverables.
  • Responsible for implementation of standards for designated functional areas
  • Responsible and may be accountable for all activities associated with relevant support function.

    • This may include :

  • Support internal site monitoring and management function by evolving process, developing and delivering training, developing and implementing monitoring oversight and supporting monitoring functional management.
  • Manage Clinical Operations Compliance related activities inclusive of holistic evaluation of CO related audit findings, execution of CAPA and process related effectiveness checks, and CO inspection readiness support and / or
  • Manage and provide operational support of the global study operating model inclusive of development and maintenance / optimization of various CO business processes and service provider related operating models (CRO, IRT, Central Lab) and / or
  • Manage the sustainability and optimization of internal and external business process standards for Clinical Operations and / or
  • Manage and provide operational support related to systems used by site monitoring and system / technology standards for the CO organization and / or
  • Management of CO QD changes and training related assignments / curriculum and staff onboarding activities
  • Provide oversight and direction to team members for functional and study-related deliverables.
  • Participate in process improvement and quality-related initiatives associated with study execution and deliverables.
  • Support and implement Study Start Up activities including global site and country level feasibility, site start up and activation, regulatory and ethics document preparation and submission.
    • Create a job alert for this search

    Operation Manager • Northbrook, IL, US

    Related jobs
    • Promoted
    Strategy & Transformation Operations Manager

    Strategy & Transformation Operations Manager

    KomatsuChicago, IL, United States
    Full-time
    Strategy & Transformation Operations Manager .Chicago, Illinois, USA, 60631 .Komatsu is an indispensable partner to the construction, mining, forestry, forklift, and industrial machinery markets, ...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Manager, Business Development, Cell & Gene Therapies

    Senior Manager, Business Development, Cell & Gene Therapies

    Fresenius Kabi USA, LLCLake Zurich, IL, United States
    Full-time
    The Senior Manager, Business Development, will play a critical role in driving global sales and business development strategy for our cutting-edge Cell and Gene Therapies (CGT) Technologies divisio...Show moreLast updated: 30+ days ago
    • Promoted
    Operations Manager

    Operations Manager

    The Everest Search GroupMundelein, IL, US
    Full-time
    Our client, a 50+ year old privately held 3rd Party Logistics Provider, have established themselves as one of the premier logistics companies in the United States. Their service offerings include, w...Show moreLast updated: 1 day ago
    • Promoted
    Manager

    Manager

    Hillco Realty ManagementHighland Park, IL, United States
    Full-time
    We are seeking a dynamic, hands-on Operations Manager to oversee a diverse portfolio within our family owned holding company. This role provides operational leadership across 12–15 multifamily prope...Show moreLast updated: 6 days ago
    • Promoted
    Director-Center Operations

    Director-Center Operations

    BY YOUR SIDE-Autism Therapy ServicesTinley Park, IL, US
    Full-time
    The BY YOUR SIDE Director – Center Operations is responsible for providing excellent parent experience to all prospective and current families by ensuring accuracy and efficiency for all comm...Show moreLast updated: 22 days ago
    • Promoted
    Operations Manager

    Operations Manager

    Power Stop LLCChicago, IL, US
    Full-time
    PowerStop is a market leader in the aftermarket automotive brake industry, holding a dominant share of brake kit sales across all major online retailers and delivering unmatched omnichannel operati...Show moreLast updated: 30+ days ago
    • Promoted
    Transmission Project Manager

    Transmission Project Manager

    nTech WorkforceOak Brook, IL, United States
    Full-time
    Candidates must be comfortable working onsite in Oakbrook Terrace on Tuesdays, Wednesdays, and Thursdays and remotely on Mondays and Fridays on a weekly basis. There will also be field visits involv...Show moreLast updated: 1 day ago
    Business Operations Manager – Site Monitoring Strategy Training and Oversight

    Business Operations Manager – Site Monitoring Strategy Training and Oversight

    AstellasNorthbrook, IL, United States
    Full-time
    Business Operations Manager – Site Monitoring Strategy Training and Oversight.Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are ...Show moreLast updated: 8 days ago
    • Promoted
    Operations Manager

    Operations Manager

    Jameson Sotheby's International RealtyChicago, IL, United States
    Full-time
    Operations Manager – Top Real Estate Team (Chicago).IKGroup at Jameson Sotheby's Cityhub is looking for a highly proactive, detail-obsessed, experienced Operations Manager with a real estate backgr...Show moreLast updated: 9 days ago
    • Promoted
    Business Development Manager - Convenience Stores (West Coast, United States)

    Business Development Manager - Convenience Stores (West Coast, United States)

    HARIBO of AmericaRosemont, IL, United States
    Full-time +1
    Business Development Manager - Convenience Stores (West Coast, United States).Start : immediately in Rosemont, IL (Remote, field-based position ideally in West Coast (CA, AZ, NV) United States) / U...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Site Operations Manager

    Site Operations Manager

    Apex SystemsPosen, IL, US
    Full-time
    Apex Systems, a World-Class Technology Solutions Provider, is seeking applicants for the below position on behalf of our client. Please apply if interested and qualified by sending an updated resume...Show moreLast updated: less than 1 hour ago
    • Promoted
    Security Operations Center (SOC) Specialist

    Security Operations Center (SOC) Specialist

    Green Thumb IndustriesMundelein, IL, United States
    Full-time
    GTIhas opportunitiesfor aSecurity Operations Center (SOC) Specialist.The successful candidate will be expected tomonitorand respondto security incidents, conduct investigations,developand implement...Show moreLast updated: 30+ days ago
    • Promoted
    Site Operations Manager

    Site Operations Manager

    Illinois StaffingChicago, IL, US
    Full-time
    The Site Operations Manager oversees daily site operations under the DOE contract, ensuring efficient and compliant IT, cybersecurity, and infrastructure support within a scientific or research-dri...Show moreLast updated: 15 days ago
    • Promoted
    Business Development Manager

    Business Development Manager

    Home Safety Services, Inc.Mundelein, IL, US
    Full-time
    Help transform the lives of seniors and their families! At Home Safety Services, we’re dedicated to improving the safety and independence of older adults by providing the most expert hom...Show moreLast updated: 1 day ago
    Business Operations Manager – Site Monitoring Strategy Training and Oversight - Now Hiring!

    Business Operations Manager – Site Monitoring Strategy Training and Oversight - Now Hiring!

    AstellasNorthbrook, IL, United States
    Full-time
    Business Operations Manager – Site Monitoring Strategy Training and Oversight.Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are ...Show moreLast updated: 8 days ago
    • Promoted
    Business Systems & Process Improvement Manager

    Business Systems & Process Improvement Manager

    John BurnsWestmont, IL, United States
    Full-time
    Business Systems & Process Improvement Manager.Founded in 1906, John Burns has a diverse, growing portfolio with a varied private and public customer base in General Contracting, Electrical Infrast...Show moreLast updated: 5 days ago
    • Promoted
    Construction Project Manager

    Construction Project Manager

    Stevens Engineers & ConstructorsHobart, IN, US
    Full-time
    Stevens Engineers & Constructors has an excellent opportunity for an experienced and highly motivated.The ideal candidate will have project management experience in industrial construction mark...Show moreLast updated: 30+ days ago
    • Promoted
    Transmission Manager

    Transmission Manager

    AkkodisOak Brook, IL, United States
    Temporary
    Title : Utility Project Manager.Location : Oakbrook Terrace IL 60181.Contract : 24 months Contract with extension.The rate may be negotiable based on experience, education, geographic location, and ot...Show moreLast updated: 1 day ago