Advanced Search
Title
Company
Description

Location:

Start New Search:

pharmacologist
activation manager
study start up
cdisc
gene therapy
outcomes research
statistician
pharmacovigilance
drug discovery
biometrics
preclinical
rna
data manager
cdm
edc
biostatistics
drug development
cra
or rn
clinical trials

Senior Site Activation Manager

Share Job
Suggest Revision
IQVIA Holdings IncSan Diego, CA
Full-time
  • The role holder may be required to cover all responsibilities mentioned below but will be expected to focus on certain responsibilities for periods of time.
  • Accountable for the oversight and execution of Start Up (from pre-award/bid defense activities up to Maintenance and Investigational Product (IP) release for all assigned projects in accordance with the agreed RSU strategy.
  • Responsible for the development, maintenance and implementation of the RSU plan according to the Scope of Work and Project Plan within the agreed strategy, escalating issues where required.
  • Ensure cross collaboration across RSU and communication with regions and countries to successfully implement the agreed RSU plan.
  • Provide overall guidance and oversight of multi-site projects during maintenance phase as an integral member of the study management team.
  • Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
  • Provide specialist regulatory and technical scientific support to facilitate efficient initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
  • Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the RSU plan.
  • Create, publish and review core scientific, technical and administrative documentation necessary for enabling study initiation and maintenance.
  • Assess and review regulatory landscape and contribute to collection, interpretation, analysis and dissemination of accurate regulatory intelligence.
  • Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required.
  • Work with Quality Management to ensure appropriate quality standards for the duration of the start up.
  • Mentor and coach colleagues as required and provide technical guidance both within and outside the project.
  • Ensure accurate completion of relevant Clinical Trial Management System (CTMS) fields in accordance with role.
  • May take a proactive role in developing long standing relationships with preferred Quintiles customers.
  • Good negotiating and communication skills with ability to challenge
  • Excellent interpersonal skills and strong team player; ability to co-ordinate and collaborate above, across and within complex projects.
  • Good regulatory and/or technical writing skills
  • Good understanding of regulated clinical trial environment and in depth knowledge of drug development process
  • Ability to exercise independent judgment taking calculated risks when making decisions
  • Good leadership skills, with ability to motivate, coach and mentor
  • Good organizational and planning skills
  • Good presentation skills
  • Understanding of study financial management
  • Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
  • Bachelor's degree in life sciences or related field with 7 years' relevant experience including demonstrable experience in an international role; or equivalent combination of education, training and experience.
  • At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.
  • The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.
  • Learn more at jobs.
  • All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
  • IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.
  • Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

Similar jobs:

Active
  • All Jobs
  • Active
Clinical Trials Manager
Kelly ServicesSolana Beach, CA
Experience in managing clinical trials or a portion of clinical trials from study start up to close out including timelines and budgeting.
Full-time
Manager, Clinical Data Management
WuXi AppTec IncSan Diego, CA
Collaborates with Project Management, Clinical Operations, Quality Control, Quality Assurance, Pharmacovigilance, etc.
Senior Statistician
WuXi AppTecSan Diego, CA
The core mission of Pharmapace is to deliver exceptional value to the life sciences industry (biotech/pharmaceutical companies) by providing high-quality consulting and outsourcing services to support our customer s clinical trials, regulatory submissions, medical affairs, safety surveillance, and outcomes research programs to help patients afflicted with a wide range of disease conditions.
Senior Director of Translational Biology - Target ID and Discovery
MeetSan Diego, CA
My client is looking for a highly motivated and innovative Pharmacologist to lead their Translational Biology team, as well as the Target ID and Drug Discovery team.
Senior Manager / Manager, Clinical Data Management
Fate Therapeutics, Inc.San Diego, CA
The Company's immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs).
Senior Clinical Trial Manager (501JT)
Fate Therapeutics IncSan Diego, CA
The successful candidate must have experience managing Phase I-III oncology trials and a good knowledge of clinical operations, ICH/GCP and FDA regulatory requirements.
Sr. Manager, Clinical Operations
BioPhaseSan Diego, CA
Demonstrated prior success in leading phase 1-3 US and international clinical studies including overseeing CRO(s) and site activities to ensure data integrity, PK samples and study drug reconciliation, and all clinical trials are conducted efficiently and in compliance with FDA regulations, ICH/GCP guidelines, and applicable country specific regulations and guidelines.
Clinical Monitoring Line Manager
University of Southern CaliforniaSan Diego, CA
Associated topics: bacteria, drug discovery, food, industrial hygienist, kinesiology, medicine, nephrology, protein, transfection, vaccine
Full-time
Contract Manager
ParexelRancho Santa Fe, CA
Knowledge of ICH/GCP in the provision of clinical trials
Biostatistician - Remote (Manager)
AscentSan Diego, CA
The contract Biostatistician will be acting as a project-level statistician.
Remote
Contract Manager
PAREXELRancho Santa Fe, CA
Knowledge of ICH/GCP in the provision of clinical trials
Full-time
Senior Director, Clinical Development
HBCU CONNECT, LLCLa jolla, CA
Janssen offers products in the following therapeutic areas: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Senior Manager, TMF Operations
XencorSan Diego, CA
Experience working within a small to midsize biotech or pharmaceutical company, TMF audits/inspections, SOP and process development and Veeva eTMF experience also required.
Senior Development Associate
Invivoscribe IncSan Diego, CA
Our global network of laboratories offer next generation molecular and flow cytometry panels to support our drug development entity and accelerate clinical trials.
Full-time
Manufacturing Manager
UC San DiegoLa Jolla, CA
The Manufacturing Manager for the UC San Diego Advanced Cell Therapy Laboratory (ACTL) oversees the manufacture, testing, and storing of cGMP cell therapy products and ensures compliance with related policies, procedures, and regulatory guidelines.