This is an excellent opportunity to join a leading global medical technology with a mission to contribute to human welfare by application of biomedical engineering in the research design manufacture and sale of instruments or appliances thatalleviate painrestore health andextend life.

The Senior Clinical Research Manager leads a highperforming team overseeing endtoend clinical research operations across ANZ. The role partners closely with regional and global operating units as well as crossfunctional teams to deliver clinical research programs from inception through completion.

Responsibilities may include the following and other duties may be assigned:

CLINICAL STRATEGY AND EXECUTION

• Strategic partner for the ANZ Commercial Operating Unit (OU) Leaders and spearheading the development of Clinical Research and Medical Science (CRMS) in ANZ aligned to the needs of the region.

• Provides input to the local clinical strategy and ensures full alignment with the global clinical strategy.

• Identifies potential local/regional clinical studies in line with local/regional and OU strategy

• Partners & collaborates with global CRMS OU Leaders to position ANZ as the place to go for pre/post market studies

• Develops and implements strategies to support regulatory function to obtain timely product approvals from regional regulatory bodies.

• Represents Medtronic from clinical research respective within the country / region and collects insights from local customers and authorities.

• Builds and maintains a strong network and close relationship with the various internal and external stakeholders.

• Leads execution for both local and global studies manages clinical research projects over all of the Medtronic therapies across multiple businesses.

• Ensures appropriate resources and priorities are maintained for the projects assigned to the geography/country.

• Develop clinical project/study and documents in collaboration with relevant stakeholders within Medtronic and oversee the execution in region.

• Assures successful & timely execution of assigned clinical programs consistent with clinical plans and applicable regulations and policies interfacing with representatives from key functional groups within Medtronic.

• Develops and manages the study- and cost centre budgets.

• Advises local marketing organization on outcome of publications and advises on a communication strategy.

PEOPLE MANAGEMENT

• Leads and manages a team of clinical professionals and related staffs including Management and supervisory professionals.

• Manages cross functional teams and stakeholders in accordance with the tasks linked to local or global clinical projects.

• Manages hiring objective setting and appraisals mainly focusing on aligning projects (objectives strategy scope and schedule) according to and to meet business plans.

• Provide leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets conducting performance reviews and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.

EXTERNAL RELATIONS

• Builds and maintains a strong network with key-opinion leaders and relevant external stakeholders (Scientific Societies Regulators Advisory Groups etc.) specific to the country/region.

• Ensures intake for investigator-initiated research ideas and ensure appropriate follow-up within the organization through the relevant policy and SOP.

• Be the first point of contact for:

  • Local customers authorities and KOLs about local Clinical Affairs

• Builds the right level of knowledge in reimbursement health management in the country/region to address those with relevant clinical solutions.

Required Knowledge and Experience:

• Requires a Masters Degree in relevant Science or biomedical field (Medicine Biomedical Engineering Medical Physics Medical Biology Health Sciences etc.) and a minimum of 10 years of experience in clinical research and operation with 5 years of managerial experience.

• Requires broad management knowledge to lead project teams in one department.

• Typically has mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function.

• Demonstrable experience in First in Human Pre-market and post market clinical study planning and execution.

• Strong knowledge of local legal and regulatory requirements for conduct of clinical trial