Clinical Outsource Manager Jobs

Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.
As the first company to fully harness the power of RNA technology for human therapeutics, Ionis’ platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. We are building upon our innovative research and drug development excellence to provide greater value to patients, and we are well positioned financially to deliver on our strategic goals.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together a diverse group of individuals with different skill sets and perspectives into this creative environment to be part of a productive and inclusive team. While acknowledging people are actively engaged in hybrid/remote work, we continue to invest time, money, and energy into making our workplace locations a place where our culture and employees can thrive. We believe engaging on a day-to-day basis, in person, builds solid and lasting relationships, and contributes positively to our culture and innovation. From the heart of our stunning Carlsbad campus, we aim to provide a central connection point for all our employees. These facilities give us the opportunity to connect cross-functionally, collaborate and to build on the success of our business as we continue to grow. Join us and experience our unique culture while you develop and expand your career.
CLINICAL OUTSOURCE MANAGER
Summary
The Clinical Outsource Manager is responsible for coordinating service provider outsourcing needs for current and future clinical trials, including vendor identification, requests for proposals (RFPs), vendor selection, contract negotiations, budget management, and service provider performance metrics. The Clinical Outsource Manager supports the Clinical Operations department in executing strategic outsourcing plans, routing agreements, reviewing budgets, and centralizing status updates on scopes of work for reporting purposes.
Core Responsibilities

• Collaborates with the CTMs and CPLs to conduct feasibility on new scopes of work for budget planning
• With input from the Clinical Operations project team, develops RFPs to ensure actionable, relevant proposals are provided by vendors to Clinical Trial Managers (CTMs) and Clinical Project Leads (CPLs); manages and influences the RFP process, competitive bidding negotiations, and proposal timelines
• May review invoices against vendor contracts to ensure accuracy and service completion; reports variance to budget or contract terms to CTMs/CPLs
• Participates in independent audits of Business Operations contract agreement repositories to ensure files are maintained in a complete and accurate fashion; may assist and support the periodic auditing of executed agreements retained in Ionis Legal’s contracts system
• Tracks and communicates status of negotiations with key internal and external stakeholders in a timely manner; tracks and communicates contract and budget issues to stakeholders that could impact project timelines and/or quality
• Tracks and reports on status of vendor contract execution; ensures that contracts are executed in a timely manner and/or escalates identified delays to supervisor
• Maintains and communicates tracking of current and potential service providers to clinical project teams
• Complies with applicable vendor selection and oversight policies and procedures
• Supports portfolio-related vendor relationships and issue resolution; knows when to escalate to Vendor Relationship Lead; works with CTMs/CPLs to monitor study-level vendor performance in accordance with contracts utilizing metrics, prior expertise, and adherence to Key Performance Indicators (KPIs)
• Participates in process improvement initiatives and/or strategic sourcing initiatives, as necessary; follows established practices for the tracking of agreement status to ensure a high-level of transparency across multiple functional areas
• Executes change order process, including collecting input from CTMs/CPLs to assess out of scope activities, negotiating contract terms and budget revisions, and tracking change order status
• Supports the Clinical Outsourcing group in the development, review, negotiation, and execution of clinical operations agreements, and may act as the first line of contact for vendors and internal team members in ensuring unit cost consistency across projects; negotiates final scopes of work, budgets, and payment schedules with input from functional stakeholders in Clinical Operations for clinical study service providers
• Collaborates with the CTMs and CPLs to provide budget accruals for vendors
• Participates in final financial reconciliation for Clinical Operations vendors, including review of site grants and pass-through reports; identifies issues and recommends solutions for vendor and/or site pass-through expenditure tracking
• May participate in efforts related to procuring and distributing supplies needed for clinical trials
• QCs work on agreements negotiated by other clinical team members across many complex contract types
• May participate in clinical hand-off or kick-off meetings to ensure key contract elements are brought to light, including service milestone prerequisites and triggers, KPIs, overall contract timelines, resourcing strategies, and, for unitized contracts, nature, and number of units
• Initiates internal requests for agreements at the request of CPLs or CTMs including but not limited to: Confidential Disclosure Agreements (CDAs), Master Services Agreements (MSAs), Service Agreements, etc.
• Travel may be required and estimated at approximately 10%
• May act as a first line contact for issue escalation related to contracts and budgets as well as vendor performance and deliverables, identifying, tracking, and reporting issues to supervisor

Competencies Identified For Success

• Outstanding organizational skills with the ability to multi-task and prioritize in a fast-paced environment
• Ability to learn new technologies with ease
• Excellent attention to accuracy and details
• Strong operational skills and demonstrated ability to meet timelines
• A team player with strong interpersonal skills; ability to resolve dynamic tensions
• Effective written and verbal communication skills
• Flexible to an ever-changing environment
• Solid analytical and proactive problem-solving skills
• Demonstrated self-starter with a high level of commitment

Requirements

• Understanding of cost drivers associated with contract types and ability to drive negotiations that ensure the best value for quality, pricing, and service
• Minimum of 2 years of experience in Clinical Outsourcing or equivalent expertise in reviewing, negotiating and executing clinical operations vendor agreements
• Understanding of drug development process
• Previous experience participating in vendor budget reconciliations
• Understanding of corporate business practices, including budgeting, forecasting, accruals, and invoice tracking
• Working knowledge of clinical study documentation related to vendor qualification, selection and oversight
• Bachelor’s degree preferred
• Knowledge of ICH‐GCP guidelines and FDA/EMA/PMDA regulations
• Strong software and computer skills, including Microsoft Office applications (Word, Excel, Outlook, SharePoint) and eClinical technologies

Please visit our website, www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition #IONIS003077
Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits
Full Benefits Link: https://www.ionispharma.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded
The pay scale for this position is $62,000 to $116,600
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.