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R＆D コントラクト＆セントラライズドサービス サイトコントラクトマネージャー（治験契約 スペシャリスト）/R＆D, Lead Site Contract Manager, Contract and Centralized Services
年収：応相談
採用企業案件
ヤンセンファーマ株式会社
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- 会社規模501-5000人
- 医薬品メーカー
| 部署・役職名 | R＆D コントラクト＆セントラライズドサービス サイトコントラクトマネージャー（治験契約 スペシャリスト）/R＆D, Lead Site Contract Manager, Contract and Centralized Services |
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| 仕事内容 |
■Position Summary: Responsible for the development and analysis of site contracts including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. The lead will assist with training of staff, facilitating clear and concise communications and assist Analysts with resolution of contracting and study related issues. In addition, the lead will provide project management and oversight to internal and external stakeholders as required and support to the clinical team in the pricing, planning, execution and control of contracts. ■Principal Responsibilities: • Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations. • Responsible for analyzing requirements and translating into appropriate contracts and budgets for clinical trial agreements and other relevant legal documents. Responsible for reviewing all study specific tracking requirements for accuracy and completeness as well as delivering against contracting cycle time targets. • Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Analyze investigator fees in relation to fair market value pricing and ensure alignment with regional standards and the J&J pricing guidelines. Participate in and/or lead approval escalations as appropriate. • Provide specialized support and guidance on negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents, as required. Determine potential needs for contract amendments and manage amendment lifecycle. Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies Provide project management oversight to CROs contracted to negotiate CTAs globally, inclusive of training and supervision to ensure adherence to timelines/targets. • Onboard and train new staff and meet regularly with team members to ensure studies are properly supported and identify contracting issues and potential solutions. Assist in resolution of site/study related concerns. Mentor and guide teams on processes and procedures. Serve as a key liaison with management on staff performance and development. Facilitate clear and consistent communications between management and other team members. Identify and implement process improvements. Drive accountability and results. • May assist in review, authorization and/or management of payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines. • Exemplary customer focus with vision to drive solutions This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned. Principal Relationships: This position reports to Manager, Site Contracting. ■Internal: • Internal Business Partners (CCS, TA, MAF, MAO, GD, HCC, Risk Management, Legal, etc.) outside parties ■External: • Clinical Investigator Sites • Commercial Suppliers • Clinical Research Organizations (when applicable). ■DECISION-MAKING AND PROBLEM-SOLVING: • Adhere to SOPs, ethics and departmental compliance as determined by GD management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with CCS GD and operating companies. Comply with requests from QA and auditors. • Onboard and train new staff and meet regularly with team members to ensure studies are properly supported and identify contracting issues and potential solutions. Assist in resolution of site/study related concerns. Mentor and guide teams on processes and procedures. Serve as a key liaison with management on staff performance and development. Facilitate clear and consistent communications between management and other team members. Identify and implement process improvements. Drive accountability and results. • Able to work independently as well as in a collaborative team environment. |
| 応募資格 |
【必須（MUST）】 Education and Experience Requirements:• Bachelor’s degree in appropriate scientific or business disciplines • 3 to 5 years-experience and/or equivalent competencies in pharmaceutical industry/clinical research • Must have a working knowledge of the clinical development process with 2 years of negotiation and contract experience • Excellent communication skills (both oral and written) • Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) Comprehensive knowledge of clinical research processes • Ability to work effectively in cross functional teams • Strong initiative and proven self-starter • Strong and proven negotiation and problem resolution skills • Working knowledge of PCs (MS Office suite at a minimum) and database management • Must demonstrate innovative spirit, have strong interpersonal skills, and ability to accomplish substantial tasks with minimal supervision; previous experience working in virtual teams preferred • Previous experience working in virtual teams preferred 【歓迎（WANT）】 • Fluency in English required.• Travel Percentage: 10% |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2023/11/01 |
| 求人番号 | 3053229 |
採用企業情報
- ヤンセンファーマ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
-
会社概要
私たちヤンセンファーマは、世界最大級のトータル・ヘルスケア・カンパニー、
ジョンソン・エンド・ジョンソン（J＆J）グループの製薬会社として、いまだ
満たされていない医療ニーズに迅速に応え、最先端の医薬品を一刻も早く患者
さんの手元に届けることができるよう取り組んでいます。
私たちは、世界57ケ国200社以上に及ぶJ＆Jグループを貫く経営理念「我が信条
（Our Credo）」を志とし、さらに、46年間に84品目もの新薬を開発したヤンセ
ン・ファーマスーティカ社の創業者、ポール・ヤンセン博士の妥協なき開発精
神を継承し、J＆Jグループの優れた新薬の導入はもちろん、医療現場への適切
かつ最新の医療情報の提供、さらには、患者さんのＱＯＬ（クオリティ・オブ・
ライフ）の向上を目指した支援活動などをおこなっています。
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です