Worldwide Clinical Trials
Senior Associate II, TMF Operations (US/Remote)
This job is now closed
Job Description
- Req#: 7530
Employer Industry: Contract Research Organization (CRO)
Why Consider this Job Opportunity:
- Competitive salary
- Opportunity for career advancement and growth within the organization
- Supportive and inclusive work environment
- Chance to make a difference in improving patients' lives through innovative therapies
- Access to a global network of professionals in the industry
- Remote work flexibility
What to Expect (Job Responsibilities):
- Perform RMC Lead Activities for 3-7 Studies, manage complex studies or Sponsor portfolio of studies
- Deputize for RMC Oversight where required
- Support TMF set-up, coordinate 'Requests for Sites to be added in eTMF' between Project Teams (PT) and eTMF administrators; review eTMF access and coordinate updates as necessary. Provide Subject Matter Expert (SME) support for Project Teams and Sponsor related to TMF.
- Oversee the QC process and make sure the RMC is on track (compliant with timelines and documentation) and follow up on non-compliance accordingly.
- Follow-up, raise, and escalate any TMF Quality issues and non-compliances in a timely manner to relevant parties.
- Support Regulatory and Sponsor audits and audits finding resolution, where necessary.
What is Required (Qualifications):
- Excellent written and verbal communication skills to clearly and concisely present information to internal and external parties.
- Ability to exercise sound judgment and identify decisions.
- Proficiency in Microsoft Word and Excel.
- Leadership skills.
- University Degree preferred (Life Science desirable).
- Combination of education plus 2-4 years of relevant experience.
- Knowledge of working within a highly regulated industry or experience of CRO/Pharmaceutical Company industry.
How to Stand Out (Preferred Qualifications):
- Experience in the contract research organization (CRO) or pharmaceutical industry.
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We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.About the company
Worldwide Clinical Trials is scientifically minded & medically driven. Our mission is to develop life-saving medicines through clinical trials, acumen, & technology.
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