Clinical Outsourcing Specialist
Ionis Pharmaceuticals, Inc., one of the 2020 Best Places to Work in San Diego, is located in the North San Diego County city of Carlsbad. Ionis was founded in 1989 and was purposely designed to create a better, more efficient drug discovery platform, establish a new innovation-centered business model, and maximize the value of every medicine created and get it to the people who need it most as quickly and as efficiently as possible.
With the RNA molecule as the basis of our novel drug discovery platform, we are targeting an unprecedented range of therapeutic areas. Our antisense therapies are disrupting diseases and changing their course—from the rarest of conditions, to those that impact millions of people. We currently have three commercial products and more than 40 potentially transformative medicines in our pipeline designed to treat a broad range of diseases.
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 individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.
CLINICAL OUTSOURCING SPECIALIST
The Clinical Outsourcing Specialist is responsible for coordinating service provider outsourcing needs for current and future clinical trials, including vendor identification, RFPs, vendor selection, contract negotiations, budget management, and service provider performance metrics. The Clinical Outsourcing Specialist supports the Clinical Outsourcing Manager in executing strategic outsourcing plans, routing agreements, reviewing budgets, and centralizing status updates on scopes of work for reporting purposes.
- Supports the Clinical Outsourcing Manager 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
- With input from the Clinical Operations project team, develops RFPs to ensure actionable, relevant proposals are provided by vendors to CTMs and CPLs; manages and influences the RFP process, competitive bidding negotiations, and proposal timelines
- Complies with applicable vendor selection and oversight policies and procedures
- Supports portfolio-related vendor relationships and issue resolution; knows when to escalate to senior management; works with CTMs/CPLs to monitor vendor performance in accordance with contracts utilizing metrics, prior expertise, and adherence to Key Performance Indicators (KPIs)
- 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 the Clinical Outsourcing Manager
- 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
- Collaborates with the CTMs and CPLs to provide budget accruals for vendors
- Tracks and reports on status of vendor contract execution; ensures that contracts are executed in a timely manner and/or escalates identified delays to the Clinical Outsourcing Manager for follow-up
- Collaborates with the CTMs and CPLs to conduct feasibility on new scopes of work for budget planning
- 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
- 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
- QCs work on agreements negotiated by other clinical team members across many complex contract types
- Distributes onboarding packets for consultants, including SOPs, Work Instructions, invoicing policies and procedures, and core business tools; collect, tracks, and maintains training files for contractors
- Works proactively with CTMs and CPLs to understand project resourcing needs; tracks and reports available contractor resources to meet the needs of clinical projects
- 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
- 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; assists and supports project teams with ensuring executed Clinical Operations agreements are filed in the Ionis TMF; may assist and support the Clinical Outsourcing Manager in the periodic auditing of executed agreements retained in Ionis Legal’s system
- Maintains and communicates tracking of current and potential service providers to clinical project teams
- 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
- Prepares annual Global Insurance workbook and collaborates with CPLs to provide accurate study information to Insurance Broker. QCs and distributes certificates upon receipt. Acts as liaison between ClinOps and Insurance Broker for any issues that may arise.
- 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,
- Travel may be required and estimated at approximately 10%
COMPETENCIES IDENTIFIED FOR SUCCESS:
- Outstanding organizational skills with the ability to multi-task and prioritize in a fast-pace environment
- Excellent attention to accuracy and details
- Effective written and verbal communication skills
- Solid analytical and proactive problem-solving skills
- Strong operational skills and demonstrated ability to meet timelines
- A team player with strong interpersonal skills; ability to resolve dynamic tensions
- Flexible to an ever-changing environment
- Demonstrated self-starter with a high level of commitment
- Ability to learn new technologies with ease
- Bachelor’s degree preferred
- 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
- Knowledge of ICH‐GCP guidelines and FDA/EMA/PMDA regulations
- Previous experience participating in vendor budget reconciliations
- Understanding of cost drivers associated with contract types and ability to drive negotiations that ensure the best value for quality, pricing, and service
- Working knowledge of clinical study documentation related to vendor qualification, selection and oversight
- Strong software and computer skills, including Microsoft Office applications (Word, Excel, Outlook, SharePoint) and eClinical technologies
- Understanding of corporate business practices, including budgeting, forecasting, accruals, and invoice tracking
Excellent salary and benefits package offered.
For more information about Ionis and to apply for this position, please click the apply button below. Reference Requisition #IONIS02354
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Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.