Amgen Part Time Senior Associate - ISS trial (12 month contract) in Hong Kong, Hong Kong

Senior Associate; Investigator Sponsored Studies

Purpose

  • Supports the Amgen specific operational activities related to the planning, review/approval, implementation, and close-out support of investigational Sponsored Studies

Responsibilities

  • Ensuring ISS studies are supported in accordance with global SOP, legislation and other supporting documentation

  • Partnering with TA/Medical staff to ensure timely and appropriate support of ISS deliverables

  • Tracking of proposals and protocols and facilitating their review/approval

  • Tracking of study budget, timeline milestones and payments to required standards

  • Tracking of Investigator Brochures, study drug/medication/supplies, and update of applicable systems

  • Participating in ISS set-up activities and sponsor support to the SOP and legislation

  • Serving as a point contact for GSM and TA/Medical Staff for ISS related issues

  • ISS Progress Reports

  • ISS review/approval and start-up documentation deliverables

  • Tracking in applicable systems

Key Activities

*Tracks receipt of ISS concepts/proposals from Investigator Sponsor and facilitates categorization, review and approval with medical personnel

*Provides protocol submission package including product-specific safety information and details of Amgen's ISS process and requirements to Sponsor

*Facilitates team review process/sign off for proposals, protocols and amendments and submits for review as per Amgen processes

*Supports the collection of ISS Approval Package (ISSAP) documents and forwards for signature approval

*Partners with Global/Regional Operations representative for drug forecasting including ancillary supplies, clinical trial labeling activities, expiry dates/memos as appropriate

*Assists Global Operations with product reconciliation and destruction

*Reviews ISS metrics and assist with measurement of compliance to process requirements

*Identifies and facilitates resolution of ISS cross-functional issues

*Initiates and ensures execution of Confidential Disclosure Agreement

*Tracks essential documentation, archives in TMF, and enters data (including milestone tracking and enrollment status) into source systems

Basic Qualifications

*Master's degree

OR

*Bachelor's degree & 2 years of directly related experience

OR

*Associate's degree & 6 years of directly related experience

OR

*High school diploma / GED & 8 years of directly related experience

Preferred Qualifications

*BA/BS/BSc or RN

*5 years work experience in life sciences or medically related field, including 2 years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company

  • A plus with experience obtained working on investigator-sponsored, industry-sponsored or industry-partnered clinical trials, or working on clinical trials at a biotech, pharmaceutical or CRO company

Knowledge

*Ability to understand technical, scientific and medical information

*Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements

*Understanding of drug development process

*Familiar with advanced concepts of clinical research

*Knowledge of relevant therapeutic or product area

*Advanced computer skills including databases

*Ability to write and present clearly using scientific and clinical issues terminology

*Experience dealing with time demands, incomplete information or unexpected events

*Good organizational and planning skills

*Experience with regulatory approval processes

*Experience working effectively in a team/matrix environment

*Experience in interactions with outside vendors, e.g. CROs and tertiary depots

*Experience with administration of budgets, contracts and payments

* This is a part time 12 month contract role with potential for renewal