Clinical Outsourcing Manager
JOB_53066841169845Job type
ContractLocation
RaleighProfession
Other/tbcIndustry
Technology & Internet ServicesPay
$85.00 - $85.00/hr.
Clinical Outsourcing Manager – Contract – Raleigh, NC – $85.00 - $85.00/hr.
The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.
Applicants must be legally authorized to work in the United States. Sponsorship not available.
Our client is seeking a Clinical Outsourcing Manager in Raleigh, NC.
Role Description
MAJOR RESPONSIBILITIES
• Lead the management (from draft initiation to execution) of contractual documents including, but not limited to:
o Work orders, agreements and amendments.
o Consultancy agreements.
o Confidentiality agreements.
o Request for Proposal (RFP) tools.
• Ensure that all UCB SOPs are adhered to and applicable laws and regulations and GCP guidelines are followed with respect to vendor selection, activity outsourcing processes and contractual documents managed by SCP.
• Drive the outsourcing process for clinical studies for assigned compounds or other clinical development activities.
• Initiate requests for information (RFI) and/or requests for proposals (RFP) customized to the outsourced services.
• Guide new vendors through clinical and IT qualification processes.
• Lead clinical study team and other clinical development activity stakeholder interactions with vendors during the outsourcing process and in case of scope updates are needed.
• Lead negotiations of vendor contracts and amendments to ensure a cost-effective, expeditious and successful solution to outsourcing needs.
• Support the clinical study teams and other clinical development activity stakeholders to identify and find solutions to issues with vendors which impede the successful outcome of the provision of services.
• Prospectively identify issues from a budget, timeline and quality perspective and prioritize rectification.
• Ensure that vendor performance is regularly assessed and shared with SCP members and relevant interfaces during regular debriefings (e.g. with stakeholders within the relevant UCB organizations , Legal, Quality, vendors, etc.).
• Participate in the development and management of a vendor management program ensuring a collaborative, transparent relationship.
• Serve as assigned vendor manager and first point of escalation for UCB’s strategic partners and preferred suppliers.
• Support financial assessments of vendors.
• Support the development of business cases.
• Contribute to the development of a global library of standard contract templates in collaboration with Legal.
• Identify business improvement opportunities and participate and/or lead in creating solutions which improve SCP efficiency and effectiveness.
• Interact on daily basis with SCP members and other relevant interfaces to ensure integration of activities.
• Support outsourcing initiatives according to the organization’s requirements.
Skills & Requirements
• At least 2 years of relevant experience in the Pharmaceutical, Biotechnology, or Clinical Research Organisation (CRO) industry. Experience with other professional services companies is an advantage. Experience managing and/or working with CROs and Service Provider in Clinical Development.
• Bachelor’s degree is required in any of several concentrations: science, finance, legal, business. Master’s degree in the same concentrations is preferred. A scientific and business background is a plus.
• Good negotiation, facilitation, and conflict management skills. A track record of successful vendor negotiations is a plus.
• Good leadership skills, networking skills, and communication skills.
• Demonstrates clear and articulate verbal, written and presentation skills with good command of the English language and the appropriate comportment to represent UCB at meetings. In all regions, fluency in multiple languages is a plus.
• General knowledge of clinical development including, but not limited to:
o FDA/EMA and other relevant regulations and guidance
o ICH/GCP and regulatory environment
o Development processes and roles/responsibilities
• Ability to identify, assess and implement best practices throughout the function.
• Proactive and flexible approach, drive and follow through.
• Independently manage multiple concurrent responsibilities in a global environment of changing priorities, without close supervision.
• Team leadership and strong people management skills
• Ability to work effectively in a global environment
• Excellent interpersonal skills
• Ability to deliver mentoring and training to peers and other groups
• Excellent verbal and written communication in English
• Proficiency in the Microsoft office
• Excellent time management and organizational skills
• Ability to forecast budget projections
• Ability to analyze, evaluate and resolve complex issues and team dynamics.
• Ability to build efficiencies and improve processes and procedures.
• Exercises independent judgment.
• Ability to achieve consensus in a group through complex and thorough deliberations.
• Support clinical programs with efficient and effective resolutions.
• Ability to work under tight timelines without sacrificing quality.
Benefits/Other Compensation
This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).
Why Hays?
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.
Nervous about an upcoming interview? Unsure how to write a new resume?
Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.
Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.
In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.
Drug testing may be required; please contact a recruiter for more information.
#LI-DNI
Applicants must be legally authorized to work in the United States. Sponsorship not available.
Our client is seeking a Clinical Outsourcing Manager in Raleigh, NC.
Role Description
MAJOR RESPONSIBILITIES
• Lead the management (from draft initiation to execution) of contractual documents including, but not limited to:
o Work orders, agreements and amendments.
o Consultancy agreements.
o Confidentiality agreements.
o Request for Proposal (RFP) tools.
• Ensure that all UCB SOPs are adhered to and applicable laws and regulations and GCP guidelines are followed with respect to vendor selection, activity outsourcing processes and contractual documents managed by SCP.
• Drive the outsourcing process for clinical studies for assigned compounds or other clinical development activities.
• Initiate requests for information (RFI) and/or requests for proposals (RFP) customized to the outsourced services.
• Guide new vendors through clinical and IT qualification processes.
• Lead clinical study team and other clinical development activity stakeholder interactions with vendors during the outsourcing process and in case of scope updates are needed.
• Lead negotiations of vendor contracts and amendments to ensure a cost-effective, expeditious and successful solution to outsourcing needs.
• Support the clinical study teams and other clinical development activity stakeholders to identify and find solutions to issues with vendors which impede the successful outcome of the provision of services.
• Prospectively identify issues from a budget, timeline and quality perspective and prioritize rectification.
• Ensure that vendor performance is regularly assessed and shared with SCP members and relevant interfaces during regular debriefings (e.g. with stakeholders within the relevant UCB organizations , Legal, Quality, vendors, etc.).
• Participate in the development and management of a vendor management program ensuring a collaborative, transparent relationship.
• Serve as assigned vendor manager and first point of escalation for UCB’s strategic partners and preferred suppliers.
• Support financial assessments of vendors.
• Support the development of business cases.
• Contribute to the development of a global library of standard contract templates in collaboration with Legal.
• Identify business improvement opportunities and participate and/or lead in creating solutions which improve SCP efficiency and effectiveness.
• Interact on daily basis with SCP members and other relevant interfaces to ensure integration of activities.
• Support outsourcing initiatives according to the organization’s requirements.
Skills & Requirements
• At least 2 years of relevant experience in the Pharmaceutical, Biotechnology, or Clinical Research Organisation (CRO) industry. Experience with other professional services companies is an advantage. Experience managing and/or working with CROs and Service Provider in Clinical Development.
• Bachelor’s degree is required in any of several concentrations: science, finance, legal, business. Master’s degree in the same concentrations is preferred. A scientific and business background is a plus.
• Good negotiation, facilitation, and conflict management skills. A track record of successful vendor negotiations is a plus.
• Good leadership skills, networking skills, and communication skills.
• Demonstrates clear and articulate verbal, written and presentation skills with good command of the English language and the appropriate comportment to represent UCB at meetings. In all regions, fluency in multiple languages is a plus.
• General knowledge of clinical development including, but not limited to:
o FDA/EMA and other relevant regulations and guidance
o ICH/GCP and regulatory environment
o Development processes and roles/responsibilities
• Ability to identify, assess and implement best practices throughout the function.
• Proactive and flexible approach, drive and follow through.
• Independently manage multiple concurrent responsibilities in a global environment of changing priorities, without close supervision.
• Team leadership and strong people management skills
• Ability to work effectively in a global environment
• Excellent interpersonal skills
• Ability to deliver mentoring and training to peers and other groups
• Excellent verbal and written communication in English
• Proficiency in the Microsoft office
• Excellent time management and organizational skills
• Ability to forecast budget projections
• Ability to analyze, evaluate and resolve complex issues and team dynamics.
• Ability to build efficiencies and improve processes and procedures.
• Exercises independent judgment.
• Ability to achieve consensus in a group through complex and thorough deliberations.
• Support clinical programs with efficient and effective resolutions.
• Ability to work under tight timelines without sacrificing quality.
Benefits/Other Compensation
This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).
Why Hays?
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.
Nervous about an upcoming interview? Unsure how to write a new resume?
Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.
Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.
In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.
Drug testing may be required; please contact a recruiter for more information.
#LI-DNI
Clinical Outsourcing ManagerJOB_530668411698452025-03-272025-06-26
JOB_53066841169845