Clinical Trials Manager Oncology
Share
Job Location:
London Borough - UK
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.
Job Description
Clinical Trial Manager (CTM)
POSITION OVERVIEW:
Clinical Operationsis responsible forthe worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performedin accordance withapplicable SOPs companypoliciesand regulatory guidelines to providetimelyand high-quality clinical data that supports global registration and commercialization of Gileads products.
You will manage a geographical region(s) of assigned clinical studies or multiple components of larger studies. You will typically manage Phase II-IIIstudies or otheroncologystudies. You will define and incorporate studylogisticsand study plans toaccomplishclinical studyobjectives. You may alsoparticipatein strategic initiatives.
EXAMPLE RESPONSIBILITIES:
Manages all components of clinical studies including Phase II-IIIstudies.
With guidance may lead contract research organization (CRO) and vendor selection and where applicablemanagesall interactions and deliverables from relevant CROs and vendors.
Typically serves as the key operational contact for Gilead studies providing oversight for thesiteevaluation initiation and close-out visits in addition to routine monitoring visits either directly or through CROs.
Defines and develops the study logistics and clinical study plan for assigned clinical studies.
Manages study timelines including documentation and communications.
Participates in and manages project meetings and conference calls with CROs other vendors and cross-functional teams.
Contributes to SOP development and/orparticipatesin special projects. Develops tools and processes thatoptimizeprojectefficienciesand effectiveness.
Provides input into study protocols and case report forms authors informed consents study plans and presentations.
Provides oversight of study sites/region and reviews routine regulatory documents to ensure that CROsare in compliance withprotocols regulatory requirements SOPs and monitoring plans.
May beto present at internal or external meetings (i.e. investigator meetings).
Leads or otherwiseassistsin the preparation of safety interim and final study reports including resolving any data discrepancies.
Proactivelyidentifiespotential operational challenges and collaborates with other Clinical Operations colleagues to provide solutions to ensure study executionremainson track to defined protocols budgets and timelines.
Assistsin training new or less experienced colleagues.
Ensuresownworkcomplies withestablished practicespoliciesand processes and any regulatory or other requirements.
REQUIREMENTS:
We are all different yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills weseekfor this role.
Minimum Education & Experience
BA / BS/ MA/ MS / PharmD / PhD or equivalent with significant relevant clinical or related experience in life sciences.
Multiple years clinical or related experience in life sciences including experience leading or managinglesscomplex studies and project teams.
Experience managing the work of external vendors.
Knowledge & Other Requirements
Experience specific to the running ofPhase II-IIIoncologystudies within the EMEA.
Experience of the regulatory and site start up requirements for clinical sites with preferably hands-on experience with filing a clinical trial application in key EMEA countries like UK EU big 5 and Israel
Demonstrated ability to be a fast learner.
Demonstrated ability to be flexible and adaptable to change to move between projects easily and provide support/expertisewhere needed.
Ability to manage anycomponentof full cycle study management from start-up to close-out.
Advanced knowledge of studymanagementbest practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.
Fully understands protocol requirements and effectively articulates and interprets these.
Knowledge of Food & Drug Administration (FDA) European Medicines Agency (EMA) and other applicable national regulations International Council forHarmonisationof Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.
Familiar with standard medical / scientific terminology.
Ability to communicate in a clear and concise manner.
Ability to support a team-orientedhighly-matrixedenvironment.
Ability to execute multiple tasks as assigned.
When needed ability to travel
The Gilead Difference
Everyone at Gilead is motivated by our overarching mission to discover and deliver innovative therapies that improve patient care in areas of unmet medical needs. Butitsjust what we do that gives us anedgeitshow we do it. We expect everyone at Gilead to lead by example guided by our core values:
Integrity(always doing the right thing)
Teamwork(collaborating in good faith)
Excellence(working ata high levelof commitment and capability)
Accountability(taking personal responsibility)
Inclusion(encouraging diversity)
We are pleased to share that Gileads Stockley Park and Holborn offices are planning to come together at a new London headquarters at 1 Triton Square NW1 fromapproximately Q22027. Applicants should consider this planned location change when applying for this role. Gileadoperatesa flexible working policy offering a balanced approach with two days of remote working and three days working onsite.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Manager
Key Skills
About Company
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensu ... View more
