Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Sr. Outsourcing Associate, Clinical Outsourcing

$130k - $146k
Full-time

Oruka Therapeutics

About Us: Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. Job Title: Sr. Outsourcing Associate, Clinical Outsourcing Location: Remote or Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park, CA will be required. Role Overview The Sr. Outsourcing Associate, Clinical Outsourcing is responsible for supporting business aspects of vendor and site agreements across defined clinical service providers and other outsourcing needs for current and future clinical trials. Responsibilities include contract negotiations, budget management, contract quality control through the support the Clinical Operations, Biometrics and Medical Affairs departments in the oversight of service provider performance. This position reports to either the Sr. Dir, Clinical Outsourcing or to the Associate Director of Clinical Outsourcing. Key Responsibilities Supports the preparation and tracking of site agreements. Monitors Progress of contract negotiation and execution and providers regular updates to all stakeholders Creates effective partnerships with vendors to cultivate and support long term relationships If applicable, negotiation of Clinical Trial Agreements and site budgets with US and Canadian sites Oversight of third-party negotiations of global Clinical Trial Agreements / Site Budgets Assists with vendor governance activities as needed Partners with vendors and internal stakeholders to identify, manage, escalate and resolve issues related to vendor performance Maintenance of Clinical Outsourcing team Outsourcing Plans, Timelines and Processes Effectively communicates, develops and cultivates operationally excellent internal cross-departmental and external vendor relationships to enable advancement of clinical development programs Negotiates change orders and ensures vendors adhere to contract terms. Assists with the generation of Request for Information (RFIs), Request for Proposal (RFPs), and assists 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) Supports the identification, development, improvement and implementation of processes and tools related to outsourcing activities Key contributing member of the Clinical Outsourcing team Minimum Qualifications Required BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered 3-5+ years of related experience in a Biotech or Pharmaceutical organization. Exposure to drug development, clinical operations and clinical outsourcing Ability to prepare/negotiate/track external provider work/change orders, etc. Ability to stay organized across multiple workstreams in a fast-paced environment Excellent negotiation skills Provide a customer service approach to internal team members Exposure to RFI/RFP development, proposal evaluation, and contract and budget management. Strong organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively Excellent computer skills including advanced knowledge in MS Excel, Word, PowerPoint, Outlook and Smartsheet Must be a self-starter Works effectively in a matrix cross-functional environment and can effectively influence stakeholders Good business judgment and a strong understanding of the unique aspects of clinical financials Must have the ability to interact with a diverse set of clinical team and functions across Oruka Therapeutics Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present budget information effectively High sense of accountability/urgency Preferred Qualifications Prior experience in small pre-revenue companies Experience in working across a wide variety of functions supporting the drug development process and specialty service vendors Experience in trials with varied outsourcing models Compensation: An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity. The anticipated salary range for candidates is $130,000 - $146,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states. We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day. Salary Range For the Role

$130,000—$146,000 USD

What We Offer: A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients. Competitive salary and benefits package. A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work. Opportunities for professional growth and development.

Vacancy posted 12 hours ago
Similar jobs that could be interesting for youBased on the Sr. Outsourcing Associate, Clinical Outsourcing in Waltham, MA vacancy
  • $270k - $290k

    Atavistik Bio, Inc. is seeking a Sr. Director of Biostatistics in Cambridge, MA. This role involves leading statistical support for clinical programs, overseeing outsourced statistics and programming teams, and providing expert biostatistical input for study designs and... 
    Outsource
    Senior

    Atavistik Bio, Inc.

    Cambridge, MA
    1 day ago
  •  ...Senior Manager/Associate Director, Clinical Data Management (Hybrid; Greater Boston, MA) How you'll make an impact: Act as Lead Data Manager, overseeing all deliverables of activities outsourced to DM CRO for multiple studies Interact and manage relationships... 
    Outsource
    Senior

    Clinical Dynamix

    Watertown, MA
    4 days ago
  • $106k - $138k

     ...Sr Associate II, Drug Safety The Sr Associate II, Drug Safety is accountable for the end...  ...the product lifecycle, including both Clinical Trial and Post-Marketing settings. This...  ...day-to-day AESI case handling activities outsourced to a vendor, ensuring that case... 
    Outsource
    Senior
    Temporary work
    Worldwide

    Biogen

    Cambridge, MA
    4 days ago
  • $145k - $200k

    Company Description Job Description The Senior Manager, Clinical Data Management (CDM) leads data management activities for clinical...  ...validated Vendor & Stakeholder Management - 10% Oversee outsourced CDM vendors and ensure performance aligns with Deciphera standards... 
    Outsource
    Senior

    Deciphera Pharmaceuticals

    Waltham, MA
    1 day ago
  •  ...inspiration and expand your capabilities, then consider a career in Advisory. KPMG is currently seeking a Senior Associate in Procurement and Outsourcing Advisory for our [1]Corporate Services Consulting practice. Responsibilities: Advise KPMG clients through... 
    Outsource
    Senior
    Full time
    H1b
    Local area

    KPMG

    Boston, MA
    a month ago
  •  ...divh2Senior Clinical Document Management Specialist/h2pIntegrated Resources, Inc is a premier staffing firm recognized as one of the...  ...inspection and internal audits. Oversees set-up and consolidation of outsourced elements of the TMF with preferred CRO vendors. With support... 
    Outsource
    Senior
    Flexible hours

    Careers Integrated Resources Inc

    Lexington, MA
    20 hours ago
  •  ...Description Job Description Responsibilities Manage all clinical data management aspects from start-up and database design...  ...on one or multiple clinical trials   Oversee all activities outsourced to clinical research organizations, including review and approval... 
    Outsource
    Senior
    Temporary work
    Flexible hours

    Crescent Biopharma

    Waltham, MA
    29 days ago
  • $230k - $281k

     ...option. At Remix Therapeutics, we intend to change that. We are a clinical-stage biopharmaceutical company that has pioneered a new class...  ...the finish line. Key Responsibilities: Lead internal and outsourced teams in end-to-end operational execution of REM-422 clinical... 
    Outsource
    Senior
    Full time

    Remix Therapeutics

    Watertown, MA
    1 day ago
  • $141k - $188k

     ...manage and ensure delivery of one or more clinical studies, including: • Partnering with...  ...and alignment with agreed strategy and associated plans. • Supports the development of...  ...review of study performance for outsourced studies, review partnership metrics to... 
    Outsource
    Senior
    Temporary work
    Local area

    Biogen

    Cambridge, MA
    1 day ago
  • A global R&D firm is looking for a Senior Manager, Clinical Partner Outsourcing in Boston, MA. This role will manage supplier contracts, ensuring seamless execution of clinical studies while addressing commercial challenges. Applicants should have over 7 years of experience... 
    Outsource
    Senior
    Contract work
    Remote work

    Takeda

    Boston, MA
    3 days ago
  • A global biopharmaceutical company in Boston is seeking a Senior Manager, Clinical Partner Outsourcing to oversee the execution of clinical studies. The ideal candidate will manage supplier contracts, ensuring alignment with business needs and timelines. Key qualifications... 
    Outsource
    Senior
    Full time
    Contract work
    Remote work

    Takeda Pharmaceuticals

    Boston, MA
    10 hours ago
  • $170k - $201k

     ...Principal, Clinical Data Management Lead The Principal, Clinical Data Management Lead...  ...across in-house, hybrid, and outsourced studies, ensuring alignment with CSL standards...  ...data standards (e.g., CDASH, SDTM) and associated validation check libraries to enable consistent... 
    Outsource
    Work at office
    3 days per week

    CSL

    Waltham, MA
    1 day ago
  • $85k - $110k

     ...across markets and service lines. This role sits at the center of how Daymark operates, translating strategy into execution across clinical operations, product, and market teams. You will work on a wide range of high-priority problems, from launching new markets to... 
    Senior
    Local area
    Remote work
    Flexible hours
    Shift work

    Daymark Health

    Boston, MA
    21 days ago
  • $115k - $135k

    Senior Specialist, Clinical Business Operations Burlington, MA Who We Are: MapLight Therapeutics is a clinical stage biotech company...  ...Trial Managers (CTM) and Clinical Scientific Leads to develop outsourcing strategy including range of vendors and timelines for award (i... 
    Outsource
    Senior
    Contract work
    Temporary work
    Work at office
    Flexible hours

    MapLight Therapeutics

    Burlington, MA
    4 days ago
  • $179k - $212k

     ...meaningful difference worldwide. Could you be our next Associate Director, Clinical Assay Strategy-Flu? The job is in our Waltham, MA Office....  ...immunogenicity endpoints. ~ Proven experience managing outsourced clinical bioanalytical programs. The expected base... 
    Outsource
    Work at office
    Worldwide
    3 days per week

    CSL Seqirus

    Waltham, MA
    20 hours ago
  • $229.98k - $277.85k

     ...Director/Sr Director, Chemical Development Watertown, Massachusetts...  ...Treeline Biosciences, a clinical-stage biotechnology company...  ...within a virtual (100% outsourced) business model, the incumbent...  ...interdisciplinary connections associated with late-phase development and... 
    Outsource
    Senior
    Fixed term contract

    Treeline Biosciences

    Watertown, MA
    4 days ago
  •  ...Parexel FSP has an exciting opportunity for a Sr. CTM. This candidate is responsible for :...  ...for implementation of one or more clinical trials and all activities from study start...  ...scope of work, supports auxiliary service outsourcing, provides input into vendor management plan... 
    Outsource
    Senior
    Contract work
    Remote work

    PAREXEL

    Boston, MA
    4 days ago
  •  ...Senior Clinical Data Manager, Clinical Data Science Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts...  ...Assists or leads with vendor selection process for outsourced CDM activities Oversees, as necessary, multiple External Service... 
    Outsource
    Senior
    For contractors
    Remote work
    Flexible hours

    Ionis Brand

    Boston, MA
    3 days ago
  • $150.5k - $245.5k

    The Senior Clinical Study Lead (CSL) is expected to operate with high degree of independence and is accountable for the global execution...  ...with the clinical trial registry requirements Identifies outsourcing needs of the study and leads and oversees engagement, contracting... 
    Outsource
    Senior

    BioSpace

    Cambridge, MA
    2 days ago
  • $131k - $196k

     ...Senior Manager, Clinical Vendor Contracts & Alliance Management, Clinical Operations Who we are: At Agios, we are fueled by...  ...strategic insight, tactical support and execution of end-to-end outsourcing activities required to successfully execute clinical studies in... 
    Outsource
    Senior
    Contract work
    Temporary work
    Work at office
    Remote work
    Work from home
    Flexible hours
    3 days per week

    Agios Pharmaceuticals

    Cambridge, MA
    3 hours ago
  •  ...divh2Clinical Research Associate/h2pIntegrated Resources, Inc is a premier staffing firm...  ...specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and...  ...activities which are not appropriate to be outsourced./ppReviews a percentage of monitoring... 
    Outsource

    Careers Integrated Resources Inc

    Lexington, MA
    2 days ago
  • $180.63k - $208.4k

    About The Role The Senior Manager, Clinical Data Management oversees clinical trial data management from startup through database lock, ensuring high-quality, reliable clinical data in support of development programs under the supervision of the Director of Clinical Data... 
    Senior

    Treeline

    Watertown, MA
    2 days ago
  •  ...Senior Clinical Trial Manager Tissium is a mission-driven medical device company founded in 2013, headquartered in Paris, with a...  ...in the execution of assigned clinical trial(s). Monitors all outsourced activities including CROs, core laboratories and other external... 
    Outsource
    Senior
    Contract work
    Work at office

    TISSIUM

    Boston, MA
    3 hours ago
  • $93k - $110k

     ...efficiency and maintaining compliance. The Sr. COE Analyst will play a key role in...  ...Aid in the management of business process outsourcing (BPO) team, including overseeing the transition...  ...and narcolepsy, and a pipeline of clinical and preclinical candidates in development... 
    Outsource
    Senior
    Full time
    Work at office
    Local area
    Shift work

    Alkermes

    Waltham, MA
    21 hours ago
  • The Senior Clinical Study Lead (CSL) operates with a high degree of independence and is accountable for the global execution of assigned...  ...with clinical trial registry requirements. Identifies outsourcing needs and leads engagement, contracting, and management of vendors... 
    Outsource
    Senior
    Contract work

    Regeneron Pharmaceuticals, Inc (USA)

    Cambridge, MA
    2 days ago
  • $137k - $215.27k

     ...boundaries of what is possible to bring life-changing therapies to patients worldwide. Objective / Purpose: The Senior Manager, Clinical Partner Outsourcing (CPO) ensures seamless execution of clinical studies by developing robust supplier contracts through commercial... 
    Outsource
    Senior
    Minimum wage
    Full time
    Contract work
    Temporary work
    Local area
    Immediate start
    Remote work
    Worldwide

    Takeda Pharmaceutical

    Cambridge, MA
    20 hours ago
  • $140.3k - $189.7k

    Overview The Sr. Manager, Clinical Operations is accountable for the end-to-end clinical trial delivery, providing operational leadership and...  ...3 registrational trials. Experience leading global trials outsourced to a CRO and ability to manage all aspects of execution of... 
    Outsource
    Senior
    Full time
    Temporary work
    Local area
    Flexible hours

    Alnylam Pharmaceuticals

    Cambridge, MA
    2 days ago
  • $26.5 per hour

     ...guidance. Job Description: The Patient Order Management Associate manages the patient order. This position is responsible for...  ...building strong relationships within accounts (clinicians and clinic staff) to retrieve documentation necessary to submit a claim to... 
    Contract work
    Work at office
    2 days per week

    C4 Technical Services

    Waltham, MA
    3 hours ago
  • $213k - $240k

     ...inclusive, and positive company culture. Job Title Director, Clinical Quality Assurance Location Remote; Waltham, MA area...  ...knowledge of sponsor oversight expectations for CROs and other outsourced clinical vendors. ~ Excellent judgment, communication, and... 
    Outsource
    Remote work

    Oruka Therapeutics

    Waltham, MA
    3 days ago
  • $236.25k - $341.25k

     ...Job title : Senior Clinical Lead, Early Clinical & Experimental Therapeutics Location...  ...the early clinical development of RAS-associated pathway inhibitor(s), as well as some pre...  .... Coordinate oversight of CROs or outsourced activities Coordinate cross-functional... 
    Outsource
    Senior
    Interim role

    Sanofi

    Cambridge, MA
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Sr. Outsourcing Associate, Clinical Outsourcing. Be the first to apply!