Job Purpose and Scope: Responsible for driving operational excellence within Affiliate Medical, working in close partnership with the local medical leadership team and area/global Operations, enabling performance improvement and enhanced decision making within the medical department through efficient and effective clinical study operation and medical affairs operations management. Promoting a culture of compliance with internal and external requirements, and of excellence in planning and execution. Subject Matter Expert and internal champion of relevant local and global systems and processes Responsible for creation, management and continuous improvement of systems and processes related to operations, to meet the changing needs and requirements of the medical department. Areas of focus are inclusive of but not exclusive to relevant systems, Plan, Long Range Plan, LBE, budget management and clinical study management, in-field excellence operations related activity, and the capture and reporting of medical metrics ensuring execution of operational plans and delivery of results Working under the direction of the Medical Director, to enable effective partnerships with internal stakeholders, including liaison and collaboration with local finance, medical project leads, medical leadership team and Area and GMA operations. Core Job Responsibilities: List the primary tasks or activities this job performs Ability to apply an enterprise mindset to deliver on business priorities and objectives, with strong business acumen; and ability to leverage business principles to support company initiatives. Line management of Medical Operations personnel, including medical in-field team excellence functions. Create, manage, continuously improve and promote systems and processes to meet the changing needs and requirements of the Medical Department. Effective budget planning, phasing, tracking and reporting in collaboration with the Medical Leadership Team, local finance, and area operations. Promoting a culture of continuous review of spend against phasing, and transparency and collaboration in budget management. Coordinate input into the Medical Plan and Long Range Plan for the medical department with internal stakeholders, including affiliate medical leads, medical leadership, finance and regional medical team. Compliant execution and tracking of IIS and Collaborative research for the affiliate, in collaboration with the Medical Director, Medical Leadership Team, Evidence Solutions Manager, Area Operations and Global Medical Research Support (MRS) and medical affairs project leads. Provide support for medical leads and coordinate affiliate level review. Provide input for quarterly Affiliate Medical Research Review meetings. Maintain Trial Master Files for Medical Affairs managed studies, vendor management (CRO, Central Labs, etc.) for operationalization and successful completion of medical affair managed studies including both local and Global MCOS. Subject matter expert on Pharma processes and requirements to facilitate communications between medical affairs project leads and external experts. Acting as the affiliate point of contact for Global/MHI operations, global MRS support, local finance and companys legal counsel (for non-company sponsored study contracts) as required. Champion and lead affiliate rollout and implementation of operational initiatives cascaded down from region and/or GMA. Maintain support for publications in affiliate, complimentary to Evidence Solutions Manager. Driving performance by enhancing transparency and providing oversight across affiliate Medical Affairs and other stakeholders to ensure effective implementation, issues management, training, compliance and oversight of in-field medical reporting as per GMA requirements. Interfacing with regional or global GMA team members as required. Sharing back metric information with the department as part of promotion of a culture of excellence. Coordination of monthly medical dashboards cross TA and functions, affiliate and AMT highlights Support additional prioritised medical projects that would further drive medical operational excellence, per direction of the Medical Director. This role directly supports the Medical Director, and in this capacity responsible for bringing a holistic perspective to execution of operational requirements. Minimum Skills Required: Identify the specific skills needed to perform this job effectively (leadership skills, selling skills, computer literacy) Strong Project (including budget) planning and management skills Ability to work independently with minimal supervision, as well as effectively work in a team environment. Effective written and verbal communication skills to individuals and groups at all levels of the organisation, and with external partners. Change management skills Good understanding of clinical study design and execution and principles of GCP, local laws and regulations. Data visualisation skills Ability to set priorities, coordinate multiple assignments, work in a fast paced, multi-tasked environment, exercising sound judgment in setting priorities with a strong attention to detail. Influencing skills. Negotiation skills Advanced understanding of in-field operational requirements and Veeva CRM system Advanced excel spreadsheet skills and a working understanding of research databases, including SPIRIT and TESLA Microsoft Office/IT skills Knowledge / Education Required: Tertiary qualification in life sciences field. Formal Project management qualifications valued (e.g. PMP Certification). GCP training preferred. Experience Required: Describe the on the job experience level required to perform this job (management experience) A minimum of 7-10 years demonstrable experience in clinical study or medical project management. Significant budget planning and management experience. Proven leadership skills to lead and influence cross-functional teams Quality, Safety & Environmental Responsibilities: Attend regular departmental meetings with manager/supervisor to build in continuous feedback mechanisms. Comply with all relevant company Occupational Health, Safety and Environmental policies, procedures and work practices with the intent of preventing or minimising accidental exposures to self, colleagues and/or the environment.
