Clinical Project Manager

ESSENTIAL FUNCTIONS:

Manage an********-ordinate efforts of cross-functional project teams tosupport milestone achievement an******** manage study issues an********an******** consistent use of study tools an******** materials an********with standar********, policies an********.
• Plan, propose, manage Clinical Research projects according toMedtronic MITG’s product registration plan, an******** timely completion
• Prepare an******** study protocol in Clinical Research includingprotocol ******** statistical analys******** etc.
• Prepare binders to Ethical Committee in Hospital for boar******** inClinical Research projects
• Prepare an******** study report in Clinical Research projects
• Manage all Investigator Sponsore******** (ISR) projects an********whole process from initiation till completion
• Visit principal investigator when protocol querie******** in ISRapplication nee******** be clarified
• Communicate with GBU about Clinical Research projects an********fluent communication an******** delivery across GBU an********
• For clinical studies with registry purpose, submit dossiers toRegulatory Affairs team about clinical data an******** thesubmitte******** are in accordance with regulatory requirements
• Manage post-market survey or surveillance studies with the samestandar******** as clinical study
• Develop study management plans, together with team assignmentsan******** an******** of database maintenance.
• Serve as primary project contact of the clinical team to ensurecommunication is maintaine******** all relevant stakeholders.
• Lea******** solving an******** efforts to include management ofr******** contingencies an********.
• Identify quality issues within the study to implement appropriatecorrective action plans. Escalate findings an******** plans toappropriate parties.
• Provide input for the development of project budgets.
• Provide input to line managers (if applicable) of their project teammembers' performance relative to project tasks.
• Prepare an******** project information at internal an********meetings.
• Ensure high performance an******** of the clinical team through thescheduling of co-monitoring/accompanie********/visits an********mentoring of CRA.


QUALIFICATIONS AND COMPETENCIES

• Bachelor's degree in life sciences or relate******** an******** yearsor above clinical research experience including 3-5 years projectmanagement experience an******** in clinical operations; or equivalentcombination of e******** training an********.
• In depth knowledge of, an******** in apply******** applicable clinicalresearch regulatory requirements; i.e., Goo******** Practice (GCP)an******** Conference on Harmonization (ICH) guidelines
• Goo******** an******** knowledge
• Strong communication an******** sk******** including goo******** ofEnglish language
• Goo******** solving skills
• Demonstrate******** to deliver results to the appropriate qualityan******** metrics
• Goo******** skills
• Excellent customer service skills
• Goo******** skills
• Goo********
• Strong software an******** sk******** including MS Office applications
• Ability to establish an******** effective working relationships withcoworkers, managers an********