Role responsible for providing operational oversight, leadership and strategic input for the execution of the assigned clinical studies (Phases I-IV). The role:
Lead operations planning, and execution of clinical studies, leveraging internal and external resources like CRO/vendors, expertise, and knowledge.
Manages day-to-day activities of all aspects for the management of clinical studies, including study plans, timelines, resources, allocation and management of product (re-)supply, problem identification and resolution, status reports and budget.
Oversee CRO/vendor selection, budget and contract negotiation and proper supervision of performance for all activities for assigned studies.
Planning and Execution
Lead operations planning, and execution of clinical studies, leveraging internal and external resources like CRO/vendors, expertise, and knowledge.
Manages day-to-day activities of all aspects for the management of clinical studies, including study plans, timelines, resources, allocation and management of product (re-)supply, problem identification and resolution, status reports and budget.
Oversee CRO/vendor selection, budget and contract negotiation and proper supervision of performance for all activities for assigned studies.
Financial Outcome
Develops and monitors study budget and timelines. Manages budgetary spend of the clinical study, communicating with the head of Clinical Operations and Project Leader.
Negotiates clinical trial agreements and budgets, managing CRO/vendor and site payments with relevant project team and Legal team members.
Recognizes and implements new methodologies that will positively impact clinical operations and costs.
Operation and Improvement
Identifies and qualifies site, as well as site start-up, initiation and conduct of the study, guaranteeing timely recruitment of study participants with secure randomization processes (if required) and closeout.
Monitors study progress, ensuring compliance with and adherence to the project plan, while identifying, assessing and resolving any problems.
Ensures efficient and effective data collection and documentation, management and analysis upon study completion, followed by final data reporting.
Performs review and provides strong operational input in the development of protocols, Informed Consent Forms and study plans
Organizes and manages multiple activities related to clinical studies of differing phases, while simultaneously ensuring clinical study timeline milestones are met and studies are completed in accordance with the protocol and ICH/GCP requirements.
Guides and ensures that the clinical study documentation (documents, images and other digital content) is correctly filed and archived, and that the study is maintained in a trial master file (TMF), so that documentation of GCP compliance is available, if required by a regulatory agency.
Supports the development and implementation of department initiatives including input on certain SOPs, processes, and workstreams
Innovation
Keeps abreast of the broad context of the industry related to commercial operations, regulations, best practices, relevant technologies and innovations.
Understands the implications for the assigned area and implements innovative operations approaches to help ensure efficient operations and achieve mandate.
Talent Development and Organization Growth
To achieve above accountabilities, what accountabilities does this position have in terms of people and organization? • Establishes collaborative working relationships with cross-functional team members service providers and CRO/vendor
In conjunction with the CRO, identifies required study specific training of the clinical staff, ensuring understanding of the drug development process and knowledge of international standards (GCP/ICH), the requirements and compliance with the appropriate health authorities (FDA/EMEA), and the application of the aforementioned to the entire study. Review protocol and case report forms (CRFs), applicable SOPs, team communications, computer software/IT training, the importance of pharmacovigilance and adverse event reporting so that all team members are not only informed, but also aligned.
External/Internal Relationship
Provides written/verbal communication to those involved in the clinical study, which includes but is not limited to study participants and internal/external team members. Communications may be reports, updates, guidance, preformed commitments, etc.
Accountable for oversight of CROs in the execution of (a) clinical study(ies). Interacts with CRO's to establish an agreed up clinical trial platform, which includes the development of effective electronic systems, the establishment of processes and plans, and mitigation strategies to identify and manage potential study risks. Partners with CRO in audit responses and addressing quality issues.
Serves as the main line of communication between the sponsor, the SPs, and the investigators.
Educational Requirements
Bachelor of Science or Bachelor of Arts degree, or the equivalent in work experience, preferably in life sciences.
Experience
3+ years of clinical trial management experience in the pharmaceutical/biotechnology industries, or with Clinical Research Organizations (CROs)
5+ years of Clinical Operations work experience. Experience must include Phase 2 and 3 studies in oncology.
Technical Skills
Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook), email and internet.
Possesses effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize.
Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs.
Cognitive Skills
Mathematical capabilities required for Performance projection and Budget management.
Demonstrated ability to effectively manage and problem-solve several complex studies with rigorous timelines; provides high quality work resulting from attention to detail and accuracy; successfully interacts and communicates with multiple internal and external process owners.
Has exhibited ability to problem-solve and effectively handle a high volume of extremely complex tasks, within a given timeline.
Has ability to evaluate options, possessing strong decision-making capabilities, and willing to take on responsibility and explain subsequent actions.
Language/Interpersonal Skills
Strong verbal and written communication and interpersonal skills, with the ability to successfully articulate plans, results and analysis to project teams so as to build commitment.
Able to interact effectively at all levels within the organization, as well as with external partners and clients.
Strong listener, as well as a communicator. Able to effectively present information in a manner to influence, and effectively answering questions of internal and external parties.
Negotiates cross-functionally, successfully motivates and influences (Clinical Development, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.) to achieve expected outcomes.
Physical Demands
Work is generally sedentary in nature, but may require standing, walking, grasping, and lifting/moving up to 15 pounds (e.g., in order to shred documents, to maintain a neat and organized work environment, and to lift paper supplies, and large boxes and files).
Work Environment
The noise level in the work environment is usually quiet.
Business Travel
This role may require the incumbent to travel, which will be primarily domestic, Travel will be scheduled based upon the needs of the business, up to 10% of the time.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of this role. (US Only)