Manager, Study Start-up & Site Contracts

Study Start-up & Site Contracts Manager

Reports to Head of Global Clinical Operations

Opportunity

The Study Start-up and Site Contracts Manager will support the GCO organization to expedite site start-up and contract execution in close collaboration with internal and external stakeholders, vendors, and investigator sites.

Responsibilities

Problem-solving

• Proactively identify potential roadblocks and challenges in the study start-up process, including site feasibility, regulatory concerns, contract discrepancies, and site activation delays.
• Develop and implement creative solutions to overcome complex study start-up issues, utilizing strong analytical skills to assess root causes and propose effective mitigation plans.
• Collaborate with clinical research sites to address site-specific challenges, providing guidance on protocol interpretation, regulatory compliance, and study documentation; meanwhile, assist in negotiating clinical trial agreements (CTAs) with research sites, ensuring favorable terms regarding study budget, timelines, and deliverables.
• Effectively communicate study start-up issues to relevant stakeholders including study team members, site investigators, and project management, facilitating timely decision-making and problem resolution.
• Identify opportunities to optimize study start-up processes, including developing new workflows, standardizing procedures, and implementing technology solutions to enhance efficiency.

Contract Management

• Ensures the timely and successful negotiation and on-going management of clinical trial agreements with investigative sites.
• Works cross-functionally across Clinical Development, Medical Affairs, Regulatory Affairs, and Program Management in support of timely site start up for the conduct of clinical trials including accurate forecast of contract execution timelines.
• Collaborates with the Functional Manager who will partner with other compliance departments to ensure country specific laws and regulations are followed to minimize risk in clinical trials
• Communicates and explains legal/ budgetary issues to internal and external parties per department guidelines.
• Reviews and evaluates client requested contract changes and based upon department guidelines escalates deviations as appropriate.
• In partnership with Clinical Operations team, and others as necessary, evaluates priorities and quickly readjusts priorities with the changing needs of business and the client.
• Identifies and proactively raises issues to the Clinical Trial Lead or Clinical Trial Manager, as appropriate, prior to their becoming critical and manages risks with clear mitigations
• Appraises contracts for completeness and accuracy and ensures adherence to department guidelines; corrects documents and files changes to contracts.
• Initiates meetings for the purpose of expediting the contract signing process as directed. Tracks all site interaction in a timely and accurate manner and ensures that status updates are fully descriptive May track and create files for all contracts.

Study Start-up

• Leads internal SSU team meetings and develop site initiation plans and collaborates with the clinical trial team as required.
• Support study start-up strategy in collaboration with key stakeholder and ensure timely start-up activities from site selection to activation
• Either directly or overseeing a CRO, collaborate with local IRBs/ECs and Health Authorities as necessary and prepare IRB/EC submission packages and review Informed Consent Forms.
• Coordinate timely responses to deficiency letters and reportable events and ensure quality and compliance of Trial Master File documents in study start-up.
• May support to oversee vendor performance to achieve start-up timelines and quality execution.

Skill/Knowledge Requirements

• Bachelor’s Degree or international equivalent, legal background or education preferred
• Minimum 5 years in the role, 2-4 years’ Experience with contracts.
• Thorough understanding of clinical trial methodologies, regulatory guidelines (e.g., GCP, ICH), and study start-up procedures.
• Proven ability to analyze complex situations, identify root causes, and develop effective solutions to resolve study start-up challenges.
• Excellent written and verbal communication skills to effectively interact with diverse stakeholders, including site investigators, study team members, and vendors.
• Experience in negotiating clinical trial agreements with research sites to achieve favorable terms for the study preferred
• Ability to manage multiple projects simultaneously, track progress against timelines, and identify potential risks to ensure study start-up milestones are met.
• Ability to work effectively in a matrixed environment.

Stemline Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.