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Manager, Strategic Outsourcing - Remote, USA
Deerfield, IL
Job Description
OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a remote Manager, Strategic Outsourcing. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
The Manager, Strategic Outsourcing, will manage the clinical trial outsourcing for Sponsor Pharmaceuticals' clinical development programs across clinical study phases pre- and post-authorization. Under the direction of the Associate Director, Strategic Outsourcing s/he is responsible for the vendor evaluation and selection, contract negotiation and maintenance, and financial management processes in support of Sponsor' clinical studies.
RESPONSIBILITIES
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
We are currently searching for a skilled professional to join a well-known client's team as a remote Manager, Strategic Outsourcing. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
The Manager, Strategic Outsourcing, will manage the clinical trial outsourcing for Sponsor Pharmaceuticals' clinical development programs across clinical study phases pre- and post-authorization. Under the direction of the Associate Director, Strategic Outsourcing s/he is responsible for the vendor evaluation and selection, contract negotiation and maintenance, and financial management processes in support of Sponsor' clinical studies.
RESPONSIBILITIES
- Assist Associate Director and senior leadership in the management of the outsourcing, vendor selection and clinical contracts process
- Generate RFIs, RFPs, and contract templates
- Assist Clinical Trial Managers with quarterly internal budget forecasts of clinical projects
- Assist Associate Director with costing trials for internal planning purposes
- Negotiate and maintain clinical development contracts, including vendor and site CDAs, MSAs, clinical site agreements, investigator meeting agreements, Work Orders for external clinical service providers, consultant agreements and specialty vendor contracts
- Oversee Functional Service Provider in the development of clinical site budgets and partner with clinical operations to ensure budgets are in line with study protocols
- Oversee CRO/FSP activities in regard to site CDAs and clinical site agreements
- Submit purchase requisitions and manage contract approvals through the legal repository system
- Interface with cross-functional teams, including legal, procurement, compliance and clinical operations functions in selection and management of vendors and study sites
- Manage selection process and develop strong relationships with vendors in conjunction with cross-functional teams
- Organize bid defense meetings as required
- Develop and maintain tracking tools (spreadsheets, databases, etc.),
- Attend team meetings as appropriate, represent Strategic Outsourcing on cross-functional clinical trial working group meetings.
- Assist in the monthly accrual process and financial reporting for projects
- Assist Associate Director with departmental process improvements as needed
- Work in collaboration with Compliance on FMV; Review Aggregate Spend Tracker for Compliance
- May help train individual contributor/professional employees
- 5 years of clinical outsourcing experience
- Minimum of Bachelor's Degree required
- Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization
- Experience generating RFPs, RFIs, and study budget/contract templates
- Proven track record negotiating contracts and budgets with both U.S. and international vendors and global clinical sites
- In-depth knowledge of compliance and legal issues related to the conduct of clinical trials phase 1 - 3. Experience with post authorization phase 4 preferred.
- Experience managing CROs, central laboratories, and other clinical study vendors, including trial sites a plus
- Understanding of international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues
- Working knowledge of clinical trial functions, including clinical operations, data management, biostatistics, regulatory and drug safety
- Ability to prioritize and handle multiple tasks simultaneously
- Maintain up to date information on changing healthcare regulations affecting clinical trial payments
- Some limited travel may be required
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You're an efficient time manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Detailed understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
5+ years
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