Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
Manage, supervise and maintain adequate clinical staff to support in-facility and out-of-facility Phase I/IIa clinical trials. Deputise for grades 33 and above.
? Manage Training, Planning and Preparation of new studies including:
o Provide oversight on team studies to ensure quality and integrity of data as per protocol and care and safety of subjects;
o Supervise and coordinating team activities to ensure that team goals are met and to ensure studies are carried out according to protocol, standard operating procedures (SOPs) and applicable guidelines and regulations and within budget;
o Plan logistical activity for procedures as per protocol and ensure thorough resource planning;
o Identify risks on study and ensuring that actions are implemented to mitigate these;
o Ensure study specific training materials, documents, and records are prepared and deliver or coordinate training, dry runs, simulations and tests as required.
? Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include:
o Plan, assign, and direct work;
o Appraise performance and guiding professional development;
o Reward and discipline employees;
o Address employee relations issues and resolving problems;
o Approve actions on human resources matters.
? Safeguarding the well-being of the subjects and ensuring and maintaining high standards by:
o Maintain a safe environment in accordance with the Health and Safety policies;
o Act as volunteer advocate;
o Deal with volunteer and visitor concerns in a pro-active manner and taking remedial action as required;
o Assist and advising staff, both registered and unregistered in Nursing Practices and the delivery of care to the volunteer;
o Report any deviation from normal practice to senior staff and implement agreed changes in care program.
? Perform and assist completion of all required protocol procedures accurately and in compliance with study-specific protocol and SOPs.
o Responsible for the correct administration and custody of medicines according to Quintiles standard operating procedures.
o Perform a variety of complex clinical procedures on subjects including but not limited to ECG, sample collection, spirometry, vital signs, cannulation, and cardiac telemetry monitoring.
o Collect, record, interpret and report clinical data and findings appropriately in case report forms (CRFs). Collaborate closely with study investigator informing on relevant adverse events and serious adverse events according to procedures outlined in the protocol.
? Update and maintain skills, training and knowledge of current best nursing practice and topics related to clinical research.
o Implement, monitor, and assess the need for training programs to maintain staff skill proficiency, including annual validation and currency of required certifications and licenses.
o Provide training to new staff members on study-specific topics and new clinical skills. Assist in ensuring compliance with staff training requirements by auditing and maintaining training records.
? Guidance and supervision of lower level staff to ensure processes are carried out in line with protocols and local SOP’s.
? Manage the unit after hours in the absence of senior staff.
? Driving quality and process improvement efforts to support control of unit budget, development of the facilities and services and the culture towards a high-performing and efficient team.
? Actively controlling department costs and driving increased profitability by evaluating study logistics and planning, managing and maintaining department resources to optimally deliver on these. Includes stock, equipment (including availability and proper maintenance thereof), bed allocations, and all process related to efficient staffing and scheduling i.e. ensuring appropriate staffing levels; developing plans for use of available resources; coordinating resources when changes occur and volunteer issues arise.
? Participate in team quality improvement efforts and required nursing meetings and in-service training programs.
? Develop, author, and review Quintiles Operating Procedures and Work Instructions.
? Drive the collection of metrics and dissemination of the results.
? Cover weekend, evening and night on-callresponsibilities as required
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
? In-depth knowledge of Phase I clinical trials
? In-depth knowledge of the principles of Good Clinical Practices (GCP) as per Quintiles mandated training.
? In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
? Proficiency in using MS Windows and Office applications such as Access, Outlook and Word
? Strong written and verbal communication skills including good command of the English language
? Excellent interpersonal skills
? Excellent problem-solving skills
? Effective organizational skills
? Effective project management skills
? Ability to pay close attention to detail
? Ability to comprehend common professional and scientific journals, financialreports, and legal documents
? Ability to work with mathematical concepts such as probability and statistical inference.
? Ability to apply principles of logical and scientific thinking to a wide variety of intellectual and practical problems.
? Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
?Bachelor’s degree, Nursing Degree or educational equivalent and 5 years relevant experience including 1 yearexperience in a leadership capacity; or equivalent combination of education, training, and experience
? Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies