Clinical Manager, Clinical Operations
Spring HealthSalary not specified
Full Time
Mid-level (3 to 4 years), Senior (5 to 8 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries
Requirements
- BA/BS in related discipline (a combination of relevant education and applicable job experience may be considered)
- 4-6 years of related experience in a Biotech or Pharmaceutical organization
Responsibilities
- Assist in the development of structure and processes supporting the newly created Clinical Outsourcing function within Clinical Operations
- Drive the creation of complex RFI and RFP document templates
- Lead and contribute to complex outsourcing initiatives and process improvement as identified
- Create effective partnerships with vendors to cultivate and support long term relationships
- Negotiate Clinical Trial Agreements and site budgets with US and Canadian sites
- Participate and assist with vendor governance activities as needed
- Partner with vendors and internal stakeholders to identify, manage, escalate and resolve issues related to vendor performance
- Manage corporate risk by working with legal to develop contracts that ensure services are completed with high quality and within budgets and timelines
- Effectively communicate, develop and cultivate operationally excellent internal cross-departmental and external vendor relationships to enable advancement of clinical development programs
- Negotiate final scopes of work, budget, and payment schedules with input from cross-functional stakeholders for clinical study service providers
- Negotiate change orders and ensure vendors adhere to contract terms
- Generate Request for Information (RFIs), Request for Proposal (RFPs), and assist Clinical Operations, Biometrics or Clinical Development with the service provider selection process including bid comparison analysis, bid defense coordination and leadership of proposal review meetings
- Oversight and execution of contract lifecycle management for assigned clinical studies, vendors and/or program(s)
- Drive the identification, development, improvement and implementation of processes and tools related to outsourcing activities
- Key contributing member of the Clinical Outsourcing team
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
Is this position remote?
Yes, the position is remote.
What are the key responsibilities of this role?
Key responsibilities include assisting in developing structures for the Clinical Outsourcing function, driving RFI and RFP templates, leading outsourcing initiatives, negotiating Clinical Trial Agreements and site budgets with US and Canadian sites, and managing vendor relationships and performance.
What is the salary or compensation for this role?
This information is not specified in the job description.
What company culture does Oruka Therapeutics promote?
Oruka Therapeutics seeks to establish an engaged, inclusive, and positive company culture, and is looking for candidates passionate about making a difference.
Who does this position report to?
This position reports to the Associate Director of Clinical Outsourcing.
Abata Therapeutics
Develops therapies for autoimmune diseases
About Abata Therapeutics
Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.
Cambridge, MassachusettsHeadquarters
2021Year Founded
$184.8MTotal Funding
EARLY_VCCompany Stage
BiotechnologyIndustries
11-50Employees
Risks
Intensifying competition from companies like Sangamo Therapeutics may impact Abata's market share.
Stringent FDA scrutiny on manufacturing could delay Abata's clinical trials.
Rising clinical trial costs pose financial risks to Abata's pipeline progression.
Differentiation
Abata focuses on Treg cell therapies for autoimmune diseases like MS and diabetes.
Their lead product, ABA 201, targets type 1 diabetes with remaining beta cell function.
Abata's strategic partnership with ElevateBio enhances their manufacturing capabilities.
Upsides
Recent investment from Bristol Myers Squibb boosts Abata's Treg therapy pipeline development.
FDA's accelerated approval pathways may expedite Abata's clinical trials.
Growing autoimmune disease prevalence increases demand for Abata's innovative treatments.
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