Job Description Summary
Core member of the Clinical Trial Team (CTT), independently managing all vendor-related aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. Accountable for vendor service delivery at study level. Collaborates closely with the Vendor Start-up Manager (VSM) for selected services (central labs, electronic clinical outcomes assessment/electronic patient reported outcomes (eCOA/ePRO), interactive response technology (IRT), cardiac and respiratory diagnostics, patient recruitment and retention (PR&R), and imaging reading) during study start-up, and leverages effectively their technical and study start-up (SSU) expertise to ensure a timely study start-up. Proactively manages vendor-related risks and potential issues. Implements global vendor strategy and if required, escalates vendor issues to the VSM while keeping Vendor Program Strategy Directors informed about risks, issues, and study progress. Oversees vendor compliance at study level.
Job Description
Key Responsibilities:
Accountable for all vendor related operational trial deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. Collaborates with the VSM for the category specific responsibilities. Responsible for all activities for which no VSM is assigned with, and for all of the service deliveries after Study Start-up when the VSM is no longer assigned to the study.
Assigned responsibilities can include but are not limited to:
• Close interaction and collaboration with study team lead and study team members during study lifetime
• Review of vendor related protocol sections during protocol development
• Collaborate with Vendor Startup Manager to the development of Study Specification Worksheet (SSW) to facilitate bid process. If no VSM is assigned to the category, drive the SSW completion.
• Manages interface with vendors in cooperation with vendor partner functions
• Quote/proposal review in collaboration with procurement, support contract negotiations, if required
• Contributes to the development of vendor contract amendments
• Accountable for vendor cost control, budget review, invoice reconciliation and PO close-out
• Vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial
• Covers all vendor activities after study start-up and all categories not covered by VSMs during start-up
• Initiates/co-ordinates vendor kick-off meeting for categories not covered by VSMs
• Attends vendor kick-off meeting for VSM supported categories
• Optimizing a frontloaded and timely study-start-up process, manages vendor-related activities for DB go live
• Performs user-acceptance testing (UAT) for eCOA and IRT
• Drives and monitors central vendor-related activities for site activation, compiles Final Protocol Package (FPP) required documents centrally, monitors site activation progress and addresses related issues and risk
• Creates and maintains vendor-related risk maps with contingency plan for documentation in FIRST
• Manages system and portal user access for vendor, sponsor and site staff, maintain access logs
• Uses Unified Vendor Portal (UVP) to manage vendor
• Uses Clinical Insights to manage vendors and to achieve site readiness timelines
• Plans and tracks supply delivery to sites and return of equipment from sites
• Interacts and collaborates with Data Ops, reviews vendor-related cycle times (e.g. DTS finalization, data transfers, DBL)
• Acts as escalation point for vendor-related query management
• Follow-up with countries and hubs for their vendor-related risks and issues
• Document issues identified with vendor oversight/performance in FIRST tool and implements and monitors corrective action
Essential Requirements:
Education:
Bachelor degree or equivalent degree is required, with advanced degree preferred.
Languages: Fluent English (oral and written).
Experience:
• 3+ years working experience and excellent knowledge of the clinical operation processes and vendor management
• Excellent knowledge of GxP and ICH regulations
• Very good knowledge of clinical trial design and mapping to supplier requirements
• Thorough and technical understanding of Novartis specifications for supplier provided services
• User Acceptance testing for eCOA and IRT
• Site collaboration and site activation
• Vendor management; outsourcing, contracting, sourcing, of clinical services
Desirable Requirements:
• Results-driven: demonstrated ability of completing projects on time
• Ability to work in cross-functional teams and a matrixed environment
• Strong influencing and negotiation skills
• Good written and oral communications skills
• Very good problem-solving skills
• Demonstrated willingness to make decisions and to take responsibility for such
• Excellent interpersonal skills (team player)
• Proven networking skills and ability to share knowledge and experience amongst colleagues.
Be aware of fake job advertisements and job offers
Novartis is aware of employment scams which make false use of our company name or leader’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money.
All our current job openings are displayed here. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information.
偽の求人広告や採用オファーにご注意ください
ノバルティスでは、当社名や幹部の名前を不正に使用して求職者をだます「採用詐欺」が発生していることを認識しています。
ノバルティスでは、面接なしに採用オファーを出すことはなく、候補者に金銭を要求することも決してありません。
現在の求人情報はすべてこちらに掲載されています。詐欺の可能性がある求人広告や採用オファーに遭遇した場合は、返信したり、金銭や個人情報を送ったりしないよう強くおすすめします。
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to midcareer- r.japan@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
ノバルティスでキャリアを築く魅力: 病気と向き合う人々やそのご家族を支えるには、革新的な科学だけでは不十分です。それには、あなたのような情熱と知性を持った仲間が必要です。
互いに協力し、支え合い、刺激し合うことで、患者さんの人生を変えるようなブレークスルーを生み出すことができます。さあ、一緒により明るい未来を創りませんか？ https://www.novartis.com/about/strategy/people-and-culture
ノバルティス・タレントネットワーク: 今のノバルティスの募集職種がご希望に合わない場合でも、ぜひタレントコミュニティにご登録ください。あなたに合ったキャリアの機会が見つかり次第、いち早くご案内いたします。 https://talentnetwork.novartis.com/network
福利厚生: ノバルティスの福利厚生と報奨について必要な情報は、ノバルティスライフハンドブックに記載されています。 https://www.novartis.com/careers/benefits-rewards
多様性と包括性へのコミットメント: ノバルティスは患者さんや地域社会などに対して、包括的かつ優れた職場環境、および多様なチームを構築するよう取り組んでいます。
合理的配慮: ノバルティスは障害を持つ個々人に対して、合理的配慮を提供し協働することをお約束します。健康状態や障害に関して、採用プロセスあるいは必須の職務を満たすために合理的配慮が必要な場合は midcareer-r.japan@novartis.com 宛てに電子メールをお送りください。その際ご依頼内容、ご連絡先、求人票の番号を明記してください。
Skills Desired
Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Model