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Site Activation Management Associate_18 month maximum term contract

Site Activation Management Associate_18 month maximum term contract
New South Wales
Lilly is a top 10 global pharmaceutical company, dedicated to creating medicines that help improve peoples' quality of life for more than 135 years. At the heart of Lilly's operations are its core values – excellence, integrity and respect for people and these are reflected in business practices that include strong governance principles, the ethical development of medicines, transparency and ethical product promotion.

Study Project Management

  • Manage the site activation processes for a study
  • Provide historical data to influence site selection discussions and provide input into the site submission strategy
  • Prepare and manage regulatory submissions to support clinical research for both internal and external clients
  • Provide guidance to internal and external customers regarding regulatory documentation, processes and other regulatory aspects of ongoing study conduct
  • Represent the SAM team in network builds, regional team meetings, and start up meetings (if appropriate)
  • Partner with study team members to ensure necessary documents are provided to SAM team within agreed upon timelines to commence the site activation process for the study
  • Coordinate and oversee the local translation process and quality for all the required trial documents
  • Be accountable for preparing country and site level ICF and amendments in compliance
with rules and regulations.
  • Be accountable for sourcing, managing, inventory and delivery of IP and non-IP supplies and its destruction as applicable
  • Initiate and maintain Country study budget activities/negotiations with Global Clinical Budgeting and Contracting (GCBC) and prepare site budgets
  • Utilize PCE and CCPM to accurately plan and forecast site activation milestones
  • Ensure that updating and tracking study-level tasks for site activation within PCE is performed as required
  • Identify potential issues with trial progress to create and implement project management and contingency plans at the study-level
  • Be accountable for the preparation of investigator Trial Master File (iTMF)
  • Prepare and maintain country TMF and ensure it is inspection ready at all times

Site Project Management

  • Drive site activation of clinical study sites
  • Develop and maintain a relationship with key site staff to influence timely collection of required regulatory documents for site activation
  • Drive Institutional Review Board (IRB) submission and approvals for trial-level regulatory
package, negotiate ICFs with IRB and maintain IRB related activities till close-out of study
  • Initiate and negotiate contracts with Institutions and investigators with an emphasis on usage of standard agreements (if applicable)
  • Accountable for the creation of the required system accounts for site personnel
  • Ensure iTMF is received by the clinical trial sites in a timely manner
  • Ensure site regulatory and SIV readiness requirements are met in compliance with applicable rules & regulations
  • Ensure accuracy and completeness of applicable site-level data for entry in IMPACT

Customer Service

  • Effectively communicate with investigator sites, study teams, GCBC, Regulatory affairs and any other relevant stakeholders regarding site activation requirements, expectations, documents, timelines and progress updates throughout the site activation period as well as during the maintenance phase of the study.
  • Collaborate with the Clinical Research Administrator (CRA), Clinical Development Liaison (CDL), Regional Country Study Manager (rCSM), Global Study Training Manager ( GSTM), and Clinical Trial Manager (CTM) to manage site activity/performance during the site activation and maintenance phases of the trial
  • Serve as primary contact for TPO and sites/investigators in case of any site activation
issues and payment issues (if applicable)
  • Review clinical trial survey results and contribute to the development and implementation of action plans to improve customer experience

Leadership and Process Improvement

  • Work with management to implement solutions related to decreasing risk and maintaining compliance
  • Participate in local and/ or regional process improvement projects
  • Serve as local Subject Matter Expert for one or more site activation related topics
  • Provide record retention expertise and consultation to the SAM department
  • Understand, comply, and drive current SAM process improvements and technology

systems (e.g., CCPM, PCE, sTMF)

Regulatory Technical Knowledge

  • Understand, comply, and reinforce local regulations, laws, and guidance (e.g., MOH, Privacy, Codes of Conduct), Medical Quality Systems (MQS) Standards and Procedures, Ethics and Compliance and Good Clinical Practices (GCP)
  • Engage in continuous learning of local and federal Regulatory guidelines, procedures, and best practices
  • Comply with Global and Local ICF requirements and serve as resource for ICF creation, approval, and revision process
  • Report identified deviations
  • Provide support before and during audits/inspections
  • Cooperate with CDL and MQR to ensure appropriate audit/inspection responses are provided and implement corrective actions
  • Provide regulatory expertise and consultation to study team members
  • Ensure ethics and compliance processes are completed in accordance with Lilly requirements and local regulations
  • Maintain local fair market value, contract, payment and any other relevant databases
  • May be required to manage IIT and ExIST trials

Administration and Clinical Operations Support

  • As needed, the SAM associate may provide support activities such as creating POs, making payments, coordination of local ISST logistics, prepare iTMF, ISST binders, etc.

Minimum Requirements

  • Preferably previous work experience in clinical trials
  • Ability to implement and execute within a fast-paced environment
  • Ability to work according to strict deadlines, prioritize and manage multiple customers
  • Strong interpersonal skills, including capability to engage in professional relationship building and networking
  • Demonstrated decision-making ability
  • Strong organizational, and problem-solving skill
  • Excellent written and verbal communication, and presentation skills
  • Strong negotiation and arbitrations skills
  • Excellent teamwork/interpersonal skills
  • Excellent customer relationship skills

Other Information/Additional Preferences:

  • ICH Good Clinical Practice knowledge
  • Previous health-related, scientific field or equivalent work experience
  • Demonstrated proficiency of computer skills (ex. Excel, Word, PowerPoint, IMPACT)
  • Self-management and organizational skills
  • Solid experience in Ethics submission and regulatory submissions