Senior Clinical Trial Manager
Constellation Pharmaceuticals is a pioneering epigenetics company, focused on the discovery and development of novel, small molecules targeting chromatin regulatory proteins in tumor and immune cells for therapeutic applications in oncology. Our unique discovery platform integrates our understanding of chromatin-regulatory mechanisms with cancer and immune pathways to optimize our drug discovery activities and fully enable the clinical translation of our programs.
We know that our success as a company lies in the hands of individual employees across every element of our company working together. To foster this success, we strive to create a diverse, challenging, exciting, and fun work environment for all employees. We believe that each team member has the ability to impact and improve the lives of patients. We are #BrighterTogether.
We are adding to our clinical team. The Sr. Clinical Trial Manager will be responsible for all aspects of clinical trial management from study start through study closure for complex global studies. You will also aid in the coordination of documentation associated with the conduct of investigational clinical studies in accordance with Food and Drug Administration (FDA) Regulations, Good Clinical Practice (GCP), and company standard operating policies and procedures.
In this role 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
- 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
- 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
- Participate 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)
- 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.)
We are looking for people who:
- Hold a BS/BA degree or equivalent; advanced degree preferred
- 4-6 years of clinical research experience with 2-4 years of study management
- Have spent at least 2 years of oncology clinical study management with at least 2 years of Sponsor side experience
- Have personally led complex, global clinical studies
- 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.
- Are a proven leader either with direct reports and/or amongst cross-functional teams
- Audit experience essential (Audit Prep 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
- Possess strong written, verbal and communication skills. Computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project
- 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
- Are excited about the vision and mission of CPI
- 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 email@example.com
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, gender expression, partnership status, status as a protected veteran, status as an individual with a 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.