Manager, Proposals & Study Start Up

About Us:

CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world-class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

Job Summary:

The Manager, Proposal & Study Start Up is responsible for managing the full lifecycle of early business capture and operational study start-up. This hybrid role integrates proposal development, feasibility analysis, startup oversight, and sponsor-facing communication. The position ensures that proposals are competitive and accurate, feasibility assessments are data-driven, and all start-up activities are executed efficiently and in compliance with regulatory standards.

The role serves as a strategic liaison between business development, clinical operations, regulatory, legal, and site leadership to support high-quality proposals and successful site activation.

Essential Responsibilities and Duties:

• Leads the development of proposals, RFIs/RFP responses, capability statements, and budget justifications.
• Performs protocol analysis to identify operational requirements, risks, and resource needs.
• Partners with SMEs (clinical, regulatory, data management, finance) to gather inputs and validate assumptions.
• Develops costing models, timelines, and operational strategies based on protocol requirements.
• Maintains proposal templates, boilerplate language, and a library of historical pricing and performance data.
• Ensures proposal accuracy, compliance, and timely delivery.
• Conducts feasibility assessments across sites, including patient availability, historical performance, and operational capabilities.
• Develops enrollment projections using historical site data and population insights.
• Analyzes sponsor feasibility questionnaires and consolidates site responses into comprehensive reports.
• Identifies feasibility-related risks and propose mitigation strategies.
• Collaborates with investigators and site operations to validate feasibility outcomes.
• Leads start-up activities from award through site activation.
• Oversees collection of regulatory documents, 1572s, CVs, training logs, and essential documents.
• Coordinates IRB submissions, contract/budget negotiation tracking, and regulatory approval workflows.
• Maintains start-up tracker, risk log, and activation timelines.
• Prepares the site for SIV, regulatory green-light, and FPI (first patient in).
• Serves as a primary point of contact for sponsors during feasibility, proposal development, and early operational planning.
• Supports sponsor qualification calls, bid defenses, kick-off meetings, and feasibility discussions.
• Provides clear timelines, expectations, and status updates to both internal and external stakeholders.
• Partners with business development on strategy, positioning, and continuous improvement.
• Maintains SOPs and templates related to feasibility, proposals, and start-up.
• Tracks KPIs such as proposal success rates, feasibility accuracy, and activation timelines.
• Ensures documentation is audit-ready and compliant with regulatory standards.
• Supports implementation of process improvements across business development and clinical operations.
• Key Performance Indicators (KPIs):  Proposal turnaround times; Proposal win/conversion rate; Feasibility accuracy (projected vs. actual enrollment); Study start-up timelines (green-light, IRB approval, SIV, FPI);  Sponsor satisfaction and feedback; Quality findings in audits related to start-up or documentation.
• Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
• Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.

Education/Experience/Skills:

• Bachelor’s degree in life sciences, healthcare, business, or related field required. Advanced degree preferred (MBA, MPH, MS).
• 3–6 years of experience in clinical research, preferably within proposal development, study start-up, feasibility, or project management.
• Experience in a site network, CRO, or sponsor environment strongly preferred.
• Solid understanding of ICH-GCP, FDA 21 CFR, and clinical trial operations.
• Excellent analytical skills and ability to interpret protocols and operational requirements.
• Ability to manage multiple competing priorities and deadlines.
• Proficiency with Microsoft Word, Excel (especially costing models), PowerPoint, and CTMS/eReg systems.
• Detail-oriented, process-driven, and proactive problem solver.
• Strong writing and communication skills; ability to produce polished, sponsor-ready deliverables.

Working Conditions

1. Indoor, Office environment.
2. Essential physical requirements include sitting, typing, standing, and walking.
3. Lightly active position, occasional lifting of up to 20 pounds.
4. Reporting to work, as scheduled, is essential.
5. Remote or Hybrid work arrangement.

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.