Our client is looking to add a Study Manager to their team on a permanent basis. Based in Cambridge, MA, this role reports to the Director of Clinical Operations and is an individual contributor to the successful achievement of the Clinical Development organizational goals.

Responsibilities:

• The Study Manager organizes, conducts and facilitates all operational activities of the assigned clinical studies (Phases I-IV), including the design, planning and coordination; maintenance of the study-level reporting systems; and the execution, tracking and creation of progress reports on the clinical trials, ensuring that the general performance and all operational aspects of the clinical studies are proceeding in accordance with the Clinical Development Plan.
• Independently 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.
• Establishes collaborative working relationships with internal members of the Clinical Development group, as well as with members of the Service Providers (SPs), consultants, contractors and colleagues from other functions, arranging for the appropriate resources and necessary.
• Interacts with CROs 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.
• 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.
• Manages budgetary spend of the clinical trial study, communicating with the head of Clinical Operations and Global Project Leader. Negotiates clinical trial agreements and budgets, managing vendor site payments with relevant project team and Legal team members.
• Responsible for site identification and qualification, as well as site start-up, initiation and conduct of the study, guaranteeing timely recruitment of trial participants with secure randomization processes (if required) and closeout. Monitors trial 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.
• Accountable for the operations planning, feasibility, and execution of a clinical protocol, the Study Manager will guide and ensure that the clinical trial 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.
• Serves as the main line of communication between the sponsor, the SPs, and the investigators.
• Responsible for regular, and as needed written/verbal communication to those involved in the clinical trial, which includes but is not limited to trial participants and internal/external team members. Communications may be reports, updates, guidance, preformed commitments, etc.
• Recognize and implement new methodologies that will positively impact clinical trial operations and costs.

Requirements / Qualifications:

• Bachelor of Science or Bachelor of Arts degree, or the equivalent in work experience, preferably in the life sciences.
• Requires a minimum of three (3) years of clinical trial management experience in the pharmaceutical/ biotechnology industries, or with Clinical Research Organizations (CROs), preferably with five (5) or more years of Clinical Operations work experience. Experience must include Phase 2 and 3 studies in oncology; additional experience in hematology, immunology and/or neurological therapeutic areas is preferred.
• Adept at working in a dynamic environment, focused on high quality results while balancing multiple priorities and deliverables, in a timely manner.
• Utilizing CROs for conducting clinical trials, successful track record of planning, conducting and managing clinical operations from early through late phase trials. Global trial experience is preferred.
• Thorough knowledge of cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs.
• Demonstration of exceptional collaborative skills and an ability to lead, understands the needs of each organization and negotiates cross-functionally, successfully motivates and influences (Clinical Development, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.) to achieve expected outcomes.
• Exhibited ability to problem-solve and effectively handle a high volume of extremely complex tasks, within a given timeline.
• Possesses effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize.
• Effective communication and interpersonal skills, with the ability to successfully articulate plans, results and analysis to project teams and senior management, so as to build commitment.
• Requires excellent organizational skills, with attention to detail.
• 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.
• Able to evaluate options, possessing strong decision-making capabilities, and willing to take on responsibility and explain subsequent actions.
• High performing and able to work independently, organizing priorities and managing project timelines, while possessing the necessary interpersonal skills and strong analytical skills that enable the successful team collaboration so as to accomplish company’s clinical strategy.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• As our client is a global company, this role may be required to attend and participate in business meetings in person or via conference call, that will be scheduled in the evening or early morning.
• 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.