The IDS Manager, under supervision of the Senior Director, is responsible for ensuring compliance with all legal, financial, and regulatory requirements are satisfied for Boston Medical Center investigational drug clinical trials. The IDS Manager also ensures that all pharmacy activities are carried out according to department mission and values, hospital core beliefs, as well as any federal or state regulations pertaining to or governing pharmacy practice and clinical research.
ESSENTIAL RESPONSIBILITIES / DUTIES:
The Investigational Drug Services Pharmacy Manager's responsibilities include but are not limited to:
- Compliance with all Federal, State and Local laws, regulations and rules governing investigational study drugs; compliance with all accreditation standards and knowledge of and adherence to all policies and procedures of the organization and department.
- Management of the day-to-day operations in the investigational pharmacy. Maintains all aspects of good clinical practice (GCP) related to proper preparation, inventory management, and dispensing/distribution/disposition of investigational products. This person must be able to do the work of the IDS pharmacists and technicians as well or better than most staff, and will guide, train and develop IS staff and study personnel to improve their skills. Maintains knowledge of the IDS technician's workflow process. Knowledge of inpatient pharmacy operations and an ability to guide those professionals as well is necessary, but less of a focus.
- Conducts pre-protocol feasibility assessments. Establishes and maintains study fee schedules, budget agreements, billing procedures, invoice approvals, and related IDS pharmacy policies and procedures.
- Assists principal investigators and study personnel with study initiation and closeout. Leads and participates in study visits with sponsors, auditors, PIs or related study personnel. Provides expertise and authoritative guidance for formulation development, preparation, dispensing, labeling, blinding, or other study design where applicable.
- Provides resources, guidance, and technical assistance to help clinical investigators locate and participate in expanded access (EA) programs. Leads the process for procurement of EA medication, contacts manufacturers and determines whether the medication manufacturer is willing to make the agent available through a single-patient IND. Verifies FDA and local IRB approval for use of the medication through non-emergency or emergency expanded access use.
- Responsible for evaluating, identifying, developing, modifying and improving IDS pharmacy operations and programs including, but not limited to staffing levels, quality assurance, and compliance activities for investigational drug protocols. Leads the development of work processes to support and/or improve efficiency, safety or otherwise support department goals and clinical research. Includes planning, identifying resources, establishing timelines and objectives and managing the execution of the work. Identifies and escalates issues.
- Supervises the creation of protocol-specific medication order templates for prescribing investigational medications, using the hospital's electronic health record when applicable. Oversees and participates in the development and maintenance of software programs designed to facilitate management of clinical investigational drug trials.
- Participates in departmental and organizational committees as assigned. Functions as the pharmacy representative on the Institutional Review Board, scientific review committees, and other Clinical Trials Office (CTO) committees. Collaborates with clinical investigators, all members of the study team and CTO to ensure safe, compliant, ethical, efficient, and timely implementation of investigational drug trials.
- Responsible for the development of training programs/manuals pertaining to preparation, dispensing and record keeping of investigational drugs. Oversees the training of IDS staff and relevant study team personnel for each investigational study. Trains additional pharmacy staff when necessary and maintains staff training records. Participates in the training and professional development of pharmacy interns and residents related to investigational drug trials.
- Assists with budgeting, including participation in the forecasting or identification of needs, financial assessments of value, negotiations on price and value through financial mechanisms and tools, as well as maintaining the IDS pharmacy charge master.
- Assist with the review and remediation of productivity, with a focus on schedule creation but including the development of a knowledge of metrics, awareness of performance in real time and demonstrating an ability to adjust to meet productive standards through flexing staff, adjusting schedules, and proactive flexible position control (e.g. recommending to the Senior Director the reduction of core FTEs through attrition or layoffs, replacing full FTEs with part time and per diems, effectively using a per diem pool etc.)Communicates effectively with a wide array of individuals ranging from pharmacy personnel, principal investigators, clinical trial coordinators, research assistants, and CTO leadership to international sponsor teams. Effectively navigates technical communications, adapts to language barriers, discovers pertinent stakeholders, and summarizes and streamlines multi-pronged discussions.
- Investigates and responds appropriately to all errors, adverse events, protocol deviations, or complaints. Responds quickly and with empathy to patient issues, and finds solutions that satisfy all parties in a timely manner. Implements effective corrective action plans when necessary.
- Participates in IDS on call coverage with other IDS pharmacy staff.
- Responsible for own continuous professional development. Stays updated on pharmacy regulations, new investigational drug products, and developments in research and design.
- Responsible for the creation and maintenance of a healthy work environment. A healthy work environment is one where people feel supported, held accountable, where standards are applied and expectations are clear. A healthy work environment is one where leadership supports and leads, models behavioral standards and sets the example for how to do all things right. Critical responsibilities related to this:
1) Being engaged in the department, including managing up, owning team decisions and communicating and supporting departmental and or organizational initiatives
2) Hold self and others to the highest ethical standards, and act with honor above all
3) Effective human resource management, including effectively disciplining people, recognizing people, completing performance evaluations and guiding people in professional development.
- Utilizes hospital's behavioral standards as the basis for decision-making and to support the hospital's mission and goals.
KNOWLEDGE AND SKILLS:
- Comprehensive understanding of the policies and procedures, systems, and equipment used by pharmacists and technicians in the handling, preparation, and dispensing of investigational drugs as well as a high level of proficiency in performing these duties and responsibilities, including hazardous and non-hazardous sterile and non-sterile compounding.
- Expertise in reviewing the use of investigational drugs and judging whether the use conforms to established standards
- Extreme attention to detail, strict adherence to policies, protocols and Good Clinical Practice standards
- Knowledge of relevant pharmacy and hospital policies including medicine storage, safety, error reporting, and patient privacy and treatment. Knowledge of all federal and state laws and regulations, FDA rules, accreditation standards and other relevant standards related to pharmacy and medication management.
- High level of analytical ability to evaluate current pharmacy services and procedures, to develop, modify and improve the program, and to organize operations in an efficient and effective manner by gathering data from a wide variety of sources through an evaluative research process.
- Leadership skills in employee supervision and HR administration to effectively lead, enact change, motivate and mentor a multi-layered staff. Conflict resolution skills to resolve personnel issues and counsel assigned staff to develop cooperative working relationships.
- High level of interpersonal skills to develop and maintain professional relationships with peers, patients, multidisciplinary team members, senior management, and assigned staff. Ability to work cooperatively and collaboratively within and across departments to coordinate Pharmacy activities and resolve problems.
- Excellent verbal and written communication. Demonstrated ability to listen actively, consider all points of view with an open mind, seek out ideas and convey information clearly.
- Ability to perform and lead effectively in stressful situations, and to evaluate and solve problems as they occur. Strong commitment to customer service to respond quickly and with empathy to patient issues. Ability to resolve patient issues and find solutions that satisfy all parties.
- Exceptionally well organized to manage multiple priorities and diverse activities in a complex, challenging environment. Demonstrates adaptability and flexibility to prioritize and meet deadlines, to anticipate and effectively handle change, to function as a role model and to ensure a concerted approach to operations.
- Strong self-management skills, sense of ownership and ability to work autonomously. . Must be a self-starter, self-motivating, have a strong work ethic and must have the ability to identify issues, resources, or opportunities that require attention.
- Dedicated team player with the willingness and desire to learn and grow within the organization
- Professional and respectful in conduct and appearance
- High level of proficiency with commonly applicable functions in clinical documentation systems, and standard software used in healthcare office setting (i.e. MS Word, Excel, Access, Outlook, web browser, etc.). Experience with pharmacy information systems (EPIC, Vestigo, DoseEdge, Pyxis, QS1) is an asset.
- Must possess and exhibit quality improvement skills and acumen.
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