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.

About The Role


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.

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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?

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:

Benefits and Rewards:
Read our handbook to learn about all the ways we'll help you thrive personally and professionally:

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- 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?


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。


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。


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- 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。


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?

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:

Benefits and Rewards:
Read our handbook to learn about all the ways we'll help you thrive personally and professionally:
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