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Site Activation Management Associate

Job Title: Site Activation Management Associate
Contract Type: Permanent
Location: West Ryde, Australia
Industry:
Salary: $65000 - $70000 per annum
Start Date: 2018-08-12
Reference: BH-84598
Contact Name: Dean Coleman
Contact Email: dean.coleman@nesgt.com
Job Published: August 13, 2018 05:34

Job Description




Site Activation Management Associate

It is an 24 month maximum term contract within the Clinical Operations team.

Responsibilities 

Manage the site activation processes for a study
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
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.
Initiate and maintain Country study budget activities/negotiations with Global Clinical Budgeting and Contracting (GCBC) and prepare site budgets
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 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



Qualifications and Skills Required:


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

 
If you would like to find out more about this role please apply now with an up to date resume or contact me on dean.coleman @ nesgt.com or call on 02 9696 8016