Study Start Up Specialist Job Vacancy in Warman O’Brien Pennsylvania – Latest Jobs in Pennsylvania
Are you looking for a New Job or Looking for better opportunities?
We got a New Job Opening for
Full Details :
Company Name : Warman O’Brien
Location : Pennsylvania
Position : Study Start Up Specialist
Job Description : We are working in close collaboration with a niche global biotech to find a Study Start Up Specialist to join them on a permanent basis. This is a remote role for now, but is likely to transition to an office-based position in PA next year.The RoleThe Study Start-Up Specialist plays a pivotal role in site initiation across the East Coast sites. You will be responsible for providing delivery and expertise in all the following functional areas: investigator site contracts, ethics and regulatory submissions, and review and finalization of essential documents required for site initiation.What will you be doing?Perform assigned activities within the US, EU and the UK, that lead to start-up of investigative sites in all phases of clinical trials, while the focus now is on early phases.Ensure an efficient start-up process on assigned studies.Act as the main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs).Directly interact with sites regarding requirements from RA or other local regulatory parties.Accountable to the PM and/or Supply Chain Manager at the project level and line manager for deliverables.Ensure local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards.Assume responsibility on quality deliverables at the country/countries) level and follows project requirements and applicable country rules.Develop, with the input from the Study team and sites a study-specific SSU plan.Forecast submission/approval timelines and ensures they are complied with; by developing a study-specific SSU plan.What can you bring?At least 1 years experience in Study Start Up.Experience in oncology/immuno-oncology early phase clinical trials essential.Cell therapy experience is a plus.Knowledge of regulation surrounding the collection of tissue and cells.Strong knowledge of current clinical trial regulations.Knowledge of resources required to permit protocol implementation.Extensive knowledge of quality assurance related to study start-up.Knowledge of electronic data management and issues affecting study start-up.What do you get in return?You will be working in a great team who have a culture of collaboration and teamwork.The opportunity to work with a diverse, dynamic leading global biopharmaceutical company who are at the cutting edge of science.Competitive salary with excellent bonus and benefits package.Flexible and dynamic working environment.What to do next?Please apply with an updated CV as soon as possible as my client is urgently looking to hire into this vacancy.Job Type: Full-timeSalary: $70,000.00 – $85,000.00 per yearBenefits:401(k)Dental insuranceHealth insurancePaid time offSchedule:Monday to FridaySupplemental Pay:Bonus payEducation:High school or equivalent (Preferred)
This post is listed Under Pennsylvania jobs
Disclaimer : Localpublic.in works to publish latest job info only and is no where responsible for any errors. Users must Research on their own before joining any company
