SanFranRecruiter Since 2001
the smart solution for San Francisco jobs

Clinical Trial Manager (Orgovyx + Combined Therapies)

Company: Aerotek
Location: Brisbane
Posted on: April 11, 2021

Job Description:

Clinical Trial Manager - Job Description Essential Duties & Responsibilities Manage protocol execution and all operational aspects on one or more clinical trials from start-up through close-out while following SOPs and ensuring compliance with country regulations and ICH/GCP guidelines Manage CRO interactions, including oversight of operational functional activities (e.g., study management, site monitoring, site management, etc.) Partner with Clinical Business Outsourcing (CBO) on CRO/CSP selection process for outsourced activities including RFP development and review, bid defense meetings, CSP performance and issue resolution Serve as CSP lead for one or more CSPs and manage one or more country/region on global clinical trials Fiscal and contracts management: collaborate with study lead, Operations Portfolio Lead (OPL), CBO and/or finance to develop and manage CRO and other CSP contract/budgets, forecast financials for CSPs and/or overall study, reconcile invoices against accruals, ensure accuracy of work order and change order updates Lead Study Management Team (SMT) meetings and Clinical Operations team meetings, as needed Lead development of internal and external study documents/plans including, but not limited to, clinical monitoring and management, Team Charter, TMF management, protocol deviation, Screening/Enrollment closure, pharmacy manual, etc. Provide input and support in development and review of key study documents including protocols, ICFs, CRFs, Clinical Study Reports (CSR), NDA submission, as appropriate Partner with Portfolio lead to develop, manage, and track study timelines against study milestones and communicate timeline risks to all internal and external stakeholders Prepare study status metrics and risk mitigations for senior management, as assigned Proactively identify potential study risks, recommend mitigation strategies/solutions and facilitate discussions for implementation Participate in and ensure quality clinical data review and data integrity for assigned clinical trial(s) Lead and serve as subject matter expert (SME) on various company working groups and participate in the development, review and implementation of departmental SOPs and processes Ensure the clinical trial(s) are inspection ready at all times and participate in Quality Assurance and/or regulatory authority inspection audits, as needed Partner with Clinical Operations Excellence and Digital Innovation group to implement innovative ideas to improve clinical trial management process and outcomes Organize and present at internal team meetings, investigator meetings, site trainings, and other trial-specific meetings Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial and conduct periodic TMF reviews, as needed Perform other duties as assigned.Description:-Strong Oncology background -Phase I study -Several study arms to it which is why she needs this resource -Imminently - need the cCTM role-Overseeing a couple vendors.-Clinical monitoring and central lab vendor-She wants to hand off the central lab vendor to the cCTM and other oversight responsibilities-Getting help from the CRO for monitoring-Need someone with strong vendor mgmt., study oversight-Once this study gets expanded - it will get busy-5 sites currently up and running and in either pre-screening and one site with patient enrolled > > all urology studies-Because they are looking to expand the study & bring on a chemotherapy drug combo > > > they are going to look at oncology sites-Needs to send out feasibility process but site selection, study startup associated with it-Will get the CDAs setup at the sites to send out the formal -Facilitate the startup of that o2 CRAs currently and will have some CTA support as wellSkills:Clinical, Research, Vendor, Management, Vendor Management, clinical trial manager, study start up, trip report review, Phase I, Phase IIA, Oncology Additional Skills & Qualifications:- Study start up experience within a biotech/ pharma company is a MUST - 3+ years of experience as a true Clinical Trial Manager already (6+ years in clinical operations total in career)Must already be a CTM - looking for someone who can jump in right away with not much training or coaching, not looking for a Sr CRA who wants to be a CTM -- Oncology experience is required, the more the better- Prefer candidates with tenured vendor management experience *someone with Oncology experience and start-up experience -Site management experience-Vendor management (will oversee a central lab). NOT using a IWRS system since it's open label-Not fully outsourced to a CRO yet -Strong site mgmt., vendor mgmt., oncology experience -Would want experience with Phase I or Phase IIAExperience Level:Expert Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, San Francisco , Clinical Trial Manager (Orgovyx + Combined Therapies), Healthcare , Brisbane, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Healthcare Jobs


Pediatric Hospitalist
Description: Pediatric Hospitalist opening in Santa Cruz, California. This and other physician jobs brought to you by DocCafe.com OverviewAn inpatient health center in California's Bay Area is looking a Pediatric (more...)
Company: KPG Provider Services
Location: Santa Cruz
Posted on: 04/12/2021

PICU Nurse - Pediatrics Intensive Care RN Travel
Description: Pediatric Intensive Care RN - Nationwide Travel Nurse Assignments Are you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are looking (more...)
Company: HealthCare Traveler Jobs
Location: Woodland
Posted on: 04/12/2021

Occupational Therapist - Travel Contract
Description: br Jackson Therapy Partners is currently seeking a licensed Occupational Therapist for a contract position at a state-of-the-art facility where expert therapy professionals help patients with injuries, (more...)
Company: Jackson Therapy Partners
Location: Santa Cruz
Posted on: 04/12/2021


General Surgeon BC/BE
Description: Palo Alto Foundation Medical Group PAFMG is seeking a full-time BC/BE General Surgeon br Location: Santa Cruz, CA br Highlights br ul br li General surgery opportunity in state-of-the-art (more...)
Company: Palo Alto Foundation Medical Group
Location: Santa Cruz
Posted on: 04/12/2021

Travel MT - Medical Technologist - Med Tech
Description: We currently have a client in Santa Cruz, CA looking for a Medical Technologist Traveling Medical Technologist Focus Staff is seeking a traveling Certified Medical Technologist, who is responsible for (more...)
Company: Focus Staff
Location: Santa Cruz
Posted on: 04/12/2021

Quick Hire- LPN/LVN Needed in West Sacramento, CA -$30 per hour (LPN/LVN #)
Description: Family Practice/Primary Care opening in West Sacramento, California. At National Staffing Solutions, we have the privilege and honor of working with dedicated healthcare professionals that make a positive (more...)
Company: National Staffing Solutions
Location: West Sacramento
Posted on: 04/12/2021

Trauma RN ICU RN - Travel Nurse Assignments
Description: Trauma ICU RN - Nationwide Travel Nurse Assignments Are you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are looking for qualified (more...)
Company: HealthCare Traveler Jobs
Location: Santa Cruz
Posted on: 04/12/2021

Travel ICU (Intensive Care Unit) RN (Registered Nurse) in Santa Cruz, CA
Description: A facility in Santa Cruz, CA is looking for a travel ICU Intensive Care Unit RN Registered Nurse . br Wherever you want your healthcare career to take you, Medical Solutions
Company: Medical Solutions
Location: Santa Cruz
Posted on: 04/12/2021

Psychiatry - Child & Adolescent - BC/BE - F/T or P/T
Description: Palo Alto Foundation Medical Group is seeking a full-time or part-time BC/BE Child/Adolescent
Company: Palo Alto Foundation Medical Group
Location: Santa Cruz
Posted on: 04/12/2021

ICU Travel RN - Job Id: JO03023064
Description: Next Travel Nursing is seeking a qualified
Company: Next Travel Nursing
Location: Santa Cruz
Posted on: 04/12/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Francisco RSS job feeds