Global Site Activation Manager

Global Site Activation Manager
Allucent, Italy

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
Qualification
Master's Degree
Total Vacancies
1 Job
Posted on
Aug 10, 2022
Last Date
Sep 10, 2022
Location(s)

Job Description

CATO SMS and Pharm-Olam, LLC have merged to form Allucent!

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment.


  • Responsible to attend the KOM and cover all aspects related the Site Activation
  • Responsible for the development of the Site Activation Management Plan (SAMP) that must be signed within 30 working days after the KOM
  • Coordination of IRB/IEC/RA submissions: will work alongside the Global Regulatory Manager to ensure submissions are performed according to internal and client expectations, support the creation of the Regulatory and Ethics Submission Plan (RESP)
  • Coordination of Site Contracts amp; Budgets: will work alongside the Global Site Contract Manager to oversee the negotiations of contracts and budgets with sites and internal team (Local Site Activation Associate(s)) according to the instructions agreed at the study level, and obtain client approval on budget increase requests if outside the allowed ranges of negotiations, support the creation of the Contract and Budget Plan (CTABP)
  • Coordination of the Investigational Product Release Authorization (if applicable): will work alongside the Global Essential Document Manager to meet client expectations for first and last site activated at study/country level, support the creation of the Investigational Product Release Authorization Plan (IPRAP)
  • Plan realistic timelines for submissions and first to last site activation at study level, day to day management during study start-up
  • Oversee the ICF process alongside the Global Regulatory Manager amp; translations of study required documents
  • Monitor site activation progress against site activation plans (SAMP, CTABP, RESP amp; IPRAP) and revise as necessary
  • Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services
  • Prepare and actively participate in internal Project Review Meetings
  • Review Site Activation budget and track out of scope budget acitivites.
  • Ensure Change Orders are requested as needed and at risk work has Senior Management approval.
  • Participate in RFP budget reviews and proposal text development
  • Present at internal and/or external meetings including Bid Defenses: prepare and deliver presentations in collaboration with relevant departments
  • Responsible for appropriate issue escalation program to appropriate stakeholder(s)
  • Serve as key client contact for assigned project(s), managing project milestones for site activation
  • Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increased potential for repeat business
  • Perform other duties as assigned by management
  • Other duties as assigned.

Requirements

  • Bachelor or higher university degree in life sciences, nursing or medical background preferred.
  • Minimum of 5-7 years relevant clinical research experience including demonstrated skills and competency in clinical project management tasks, especially regarding study start up in the pharmaceutical or biotechnology industry.
  • Demonstrated ability in a leadership capacity and thorough knowledge of European/CEE/ROW regulatory submission and reporting requirements and guidelines.
  • Indepth knowledge of ICH Guidelines and GCP including international regulatory requirements for tbe conduct of clinical development programs.
  • Detailed knowledge of financial control procedures (i.e. costing systems, time reporting).
  • Indepth knowledge of project management processes, especially concerning study start up.
  • Attention to detail with excellent oral and written communications skills .
  • Able to thrive in a stressful environment and ability to work with changing priorities and to utilize resources effectively.
  • Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system
  • Able to perform well as a team member.
  • Ability to negotiate and liaise with clients in a professional manner.

Job Specification

Job Rewards and Benefits

Allucent

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