Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons email@example.com
The Senior Manager of Clinical Operations will, in partnership with senior management, implement and manage early and late phase human clinical studies to achieve the project and corporate objectives. This position will work with cross-functional team members, clinical research organizations, and consultants to ensure the successful, cost-effective, and timely execution of clinical studies (including proof-of-concept study). Responsibilities will also include managing across clinical sites in coordination with CROs, tracking and ensuring projected enrollment, and coordinating sample analyses and data management activities. It is expected that he/she will manage the conduct of clinical trials that meet the business and product development goals of the Company.
ESSENTIAL FUNCTIONS: To perform this job successfully an individual must be able to perform each essential functions satisfactorily.
- Functions as the Study Team Lead (STL) in managing the clinical operations team and cross-functional clinical trial team in the planning, execution and reporting of clinical trials
- Manages external resources such as consultants, contractors, CROs.
- Responsible for managing study budgets including forecast and invoice approvals
- Coordinates vendor meetings and review vendor documents (e.g., manuals, Master Service Agreements, contracts) for adequacy.
- Develops Project Plans to include timelines and milestones.
- Prepares and/or supports Clinical documents (e.g., protocols, study reference manuals, documents to be submitted to Regulatory agencies or ethics boards), Standard Operating Procedures, guidelines, and departmental policies.
- May identify and assist in departmental training requirements including internal and external operations.
- Ensure all clinical activities are delivered in accordance with expectations, trial protocol, ICH/GCP guidelines and applicable SOPs and regulations (local/US/international)
- May supervise direct reports and matrixed study team.
- Other duties and responsibilities as assigned.
- Knowledge of GCP, ICH guidelines and FDA regulations. Familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements is a plus.
- Understanding of the principles of project management and proven ability to lead a project team.
- Prior experience with managing multi-center studies with a keen understanding of all aspects of Clinical Operations, including: clinical trial design, study implementation/start-up activities, CRA and site management, data management (to database lock and data analyses).
- Must possess a professional demeanor and effective communication capabilities for collaboration with others in a multi-disciplinary group.
- Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures. Must be focused and able to meet tight timetables.
- Adaptable and able to work in a work environment where priorities are constantly changing.
- Ability to effectively present ideas and document concepts in writing and orally.
- Excellent computer literacy with working knowledge of PCs, Windows and Microsoft Office applications.
- Ability to travel, in some cases, internationally (Average travel expectations: approximately 25%).
- Bachelors degree or RN degree plus 6-8 years of experience in biotechnology or pharmaceutical industry. A higher degree is a plus.
- 6 years of experience in Clinical Operations roles with minimum 2 years as a
- manager or above in a biotechnology or pharmaceutical company with direct involvement in early phase human clinical trials
- In-depth experience soliciting CRO and key vendor proposals, critically evaluating
- competing proposals, negotiating key terms, and selecting/initiating these relationships
- In-depth experience with drug development issues is required
- Experience interacting directly with clinical sites is required
- Experience in reviewing or writing of clinical protocols, study manuals, case report forms, and informed consent forms is required
- Ability to present technical and business aspects of projects
- Forward-thinking and creative with high ethical standards
- Team player with leadership skills
- Able to work in a fast-paced environment with drug development professionals
- Well organized and self-directed
- Strong interpersonal skills with an ability to communicate to people at all levels of an organization