CLINICAL OUTCOMES MANAGER jobs in Hamden, CT

Overview

The Manager/Associate of Grants and Contracts (MGC) plays a key role in advancing critical activities within the Clinical Development team and will report to the Sr. Manager, Grants and Contracts.

Responsibilities

• Independently negotiates initial or amended site Clinical Trial Agreements (CTAs) and budgets, and/or serves as escalation point and oversight for CROs negotiating site CTAs and budgets in support of assigned global Clinical Studies.
• Independently negotiates other initial or amended clinical Agreements such as Investigator Initiated Research Agreements (IIRs), Confidential Disclosure Agreements (CDAs), Consulting Agreements, as well as Vendor Agreements such as Master Services Agreements (MSAs), Statements of Work (SOWs), and Change Orders (COs).
• Ensures appropriate Data Privacy language is included in applicable ex-US contracts per GDPR guidance
• Oversees CRO development and review/approval of country-specific site CTA and budget templates
• Liaises with legal, manager, and study team members as necessary to ensure contracts and budgets are finalized, executed, logged and filed in accordance with Celldex standards and within the timeline needed to meet key company milestones
• Tracks ongoing projects and maintains supporting documentation for MGC role
• Gathers, populates, and oversees the review of monthly accrual data for assigned clinical studies and liaises with Clinical Operations and Finance to ensure accurate financial reporting with supporting documentation. Delivers rationale for study-specific approaches in collaboration with team.
• Attends meetings with finance, clinical operations, study teams, CROs, manager, and other internal or external parties to ensure full understanding of assignments including overall timelines and deliverables. Represents grants and contracts function as assigned and provides status updates, notes any gaps in contractual coverage or new items needed based on project status or changes. Tracks any MGC action items and moves them forward until completion.
• May assist manager with review of internal contract or budget templates or MGC processes and provide input as requested
• May assist clinical team in vendor selection/RFP process
• May be responsible for populating site payment data for studies not outsourced to a CRO, and/or reconciling internally or externally managed final site payments

Qualifications

• At least 1 year relevant experience directly negotiating clinical site and vendor contracts, experience negotiating ex-US contracts a plus
• 3 years in a clinical development or clinical operations team with a pharmaceutical company, CRO, or investigator site
• Understanding of healthcare compliance and other relevant guidance including GCP, HIPAA, FCPA
• Experience with EU GDPR guidance and managing data privacy terms a plus
• Bachelor's Degree required, Juris Doctorate or paralegal a plus
• A combination of experience and education may be substituted
• Experience will determine level (MGC or Assoc. MGC)
• Strong Microsoft skills including Word, Excel, Teams, and Sharepoint
• Ability to review tracked changes and comments from multiple reviewers within a document and collate/ combine feedback, rewording as appropriate before returning to external parties
• Ability to manage a high volume workload independently and the agility to prioritize more urgent tasks based on project timelines, company goals, and manager directives

About Advanced Clinical
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.