Sr. Clinical Trial Manager
Constellation Pharmaceuticals is a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics. Our employees are our single greatest asset. We know that our success lies in the hands of each individual in every corner of the company. We strive to create a work environment that is diverse, challenging, exciting, and fun. We believe that each team member has the ability to impact and improve the lives of those we work with, and those we work for—our patients. We are #BrighterTogether.
We are seeking a Sr Clinical Trial Manager (CTM) or experienced CTM to plan, implement and conduct large, global, complex clinical trials. This is a rare opportunity for experienced individuals to pool their learning and drive Constellation’s first Phase 3 trial as well as earlier-stage trials in Phase 1 and 2. The Sr. CTM will provide leadership within the department and critical guidance with regards to the operational aspects of executing clinical development deliverables.
How you will spend your day:
Clinical Trial Management
- You will serve as the clinical point person managing protocol execution, including the oversight of CROs, vendors, and consultants that are involved with the clinical trials and programs.
- You will lead/coordinate clinical study management meetings, both internal and external, as required.
- You will be given the opportunity to train and mentor team members and site staff, including vendors, as needed.
- Perform clinical research site activities, such as onsite/remote and/or co-monitoring as needed.
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, to include data entry, drug delivery, sample management, etc.
- Ensure trial adherence to ICH/GCP/Federal and Global HA regulations.
- You will assist in the development of study documents such as Informed Consent, Protocol, Investigator Brochure, study tools, etc.
- Assist with the development of the clinical components of regulatory submissions e.g. safety, interim and final study reports as needed.
- Responsible for oversight of individual studies as well as relevant program-related activities.
- Participate and respond to Quality Assurance and/or regulatory authority inspection audits.
Fiscal and Contracts Management
- Participates in contract and budget negotiations with CROs, clinical sites, vendors and consultants.
- In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents.
- Manage clinical trial SOW and budgets, providing ongoing financial reporting and projections to finance group.
- Responsible for the creation and management of program-level budget(s).
Cross-Functional Mentoring and Leadership
- Work cross-functionally to ensure clinical program timelines and goals are met.
- Provide study-specific mentoring and line management for junior team members, as appropriate.
- Assume a leadership role in operational improvement initiatives (e.g. SOP development, training, etc.).
Key things about you:
- You hold a bachelor’s degree in health sciences or related field.
- You can offer a minimum of 4-6 years of experience in clinical research with at least 2- 4 years of experience in study management.
- You have spent at least 2 years of oncology clinical study management
- Strong experience with personally leading complex, global clinical studies.
- You will have experience in management of CROs, vendors, and consultants to include contracts, budgets, site selection, review and development of trial plans (including pharmacy and lab manuals), CRFs and other data management documents, etc.
- You will be a proven leader either with direct reports and/or amongst cross-functional teams.
- Audit experience essential (Audit Prepp or Mock Audit experience would be considered) as well an ability to apply quality and risk management principles
- Monitoring Experience preferred.
- Documented training of GCP and ICH; knowledge and application of Federal and Global HA guidelines.
- You will possess strong written, verbal and communication skills. Computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.
- You are a passionate, adaptable person who thrives in fast-paced, entrepreneurial environments with busy, high performing colleagues.
- Recognized by former colleagues, customers, managers and/or direct reports for attributes congruent with CPI FIRST Values: Focus, Integrity, Respect, Science, Teaching
- You are excited about the vision and mission of CPI
- You will have the flexibility to travel as required.
Don’t see the position you’re looking for? We want to hear from you regardless! Please submit your CV to us at firstname.lastname@example.org
Constellation Pharmaceuticals recognizes the value of diversity in our workforce. We are committed to equal opportunity. We consider all qualified employment applicants without regard to race, religion, color, gender, age, national origin, sexual orientation, gender identity, partnership status, protected veteran status, disability, or any other status protected by federal, state, or local law. Individuals who hold legal work authorization applicable to employment at Constellation Pharmaceuticals in the United States will be considered without regard to citizenship/alienage. Constellation Pharmaceuticals is a participant in E-Verify.
We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.