Clinical Project Manager
IQVIA
Clinical Project Manager
Job Description
Job OverviewAccountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget. The Clinical Project Manager leads the regional clinical operations team (including oversight of external partners working on the regional level) and acts as point of escalation for resolution of issues within the region for the assigned study. Ensures alignment of regional deliverables with overall study goals.Essential FunctionsLeads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study Leads external vendors involved in study delivery on a regional levelCollaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Project Manager as requiredRepresents the regional project team at internal meetings and at the cross-functional Clinical Project Team (CPT) meetingsLeads regional operations meetings with all regional project team membersLeads planning and management of the assigned clinical projects from feasibility through closeout activities for region, in line with global project timelinesGenerates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards theseEnsures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders Provides regional input on global study plans as requiredEnsures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBsAccountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairsEnsures regional and country information in study systems and tools is entered and up to dateCollaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs-off monitoring reportsResponsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC’d on a regular basis as per the study TMF QC planProvides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in regionManages the trial data collection process for the region, drives data entry and query resolutionAs required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Project Manager and Medical WritingHandles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country headsMonitors study activities in region to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulationsEnsures inspection readiness for study in region at any point in time throughout the study life cycleInforms Global Clinical Project Manager of any issues arising on the study, evaluates impact and ensures solutions are implementedPrepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriateCollaborates with CPT members and colleagues to ensure cross-team, site learnings, and best practices are sharedLeads improvements and partners with CPT members to enhance the efficiency and the quality of the work performed on assigned studiesContributes to development, optimization and review of work instructions and SOPs as requiredWorks with the sourcing team to select and manage regional study vendorsManages regional study budgetsWorks closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activitiesIdentifies and manages regional team resource needs and establishes contingency plans for key resourcesMonitors regional resource utilization over study life cycle and liaises with functional managers as neededQualificationsBachelor's Degree Life sciences or related fieldProgressive experience in clinical research within biotech, pharma or CRO industry7 years of monitoring experience including > 1 years project management experience or equivalent combination of education, training and experience.Advanced knowledge of job area, and broad knowledge of other related job areas, typically obtained through advanced education combined with experience.Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge; therapeutic knowledge desired.Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Locations
- Malaysia, Wilayah Persekutuan Kuala Lumpur
Skills Required
- clinical research within biotechintermediate
- job areaintermediate
- other related job areasintermediate
- clinical trials - Knowledge of clinical trial conductintermediate
Required Qualifications
- Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs (experience)
- Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs (experience)
- Ensures regional and country information in study systems and tools is entered and up to date (experience)
- Collaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs-off monitoring reports (experience)
- Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC’d on a regular basis as per the study TMF QC plan (degree in working with regional and country teams to ensure that country and site level trial master file is created)
- Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region (experience)
- Manages the trial data collection process for the region, drives data entry and query resolution (experience)
- As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Project Manager and Medical Writing (experience)
- Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads (experience)
- Monitors study activities in region to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulations (experience)
- Ensures inspection readiness for study in region at any point in time throughout the study life cycle (experience)
- Informs Global Clinical Project Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented (experience)
- Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate (experience)
- Collaborates with CPT members and colleagues to ensure cross-team, site learnings, and best practices are shared (experience)
- Leads improvements and partners with CPT members to enhance the efficiency and the quality of the work performed on assigned studies (experience)
- Contributes to development, optimization and review of work instructions and SOPs as required (experience)
- Works with the sourcing team to select and manage regional study vendors (experience)
- Manages regional study budgets (experience)
- Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities (experience)
- Identifies and manages regional team resource needs and establishes contingency plans for key resources (experience)
- Monitors regional resource utilization over study life cycle and liaises with functional managers as needed (experience)
- Bachelor's Degree Life sciences or related field (degree in related field)
- Progressive experience in clinical research within biotech, pharma or CRO industry (experience)
- 7 years of monitoring experience including > 1 years project management experience or equivalent combination of education, training and experience. (experience, 7 years)
- Advanced knowledge of job area, and broad knowledge of other related job areas, typically obtained through advanced education combined with experience. (experience)
- Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge; therapeutic knowledge desired. (experience)
- Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills. (experience)
- Bachelor's Degree Life sciences or related field (degree in related field)
- Progressive experience in clinical research within biotech, pharma or CRO industry (experience)
- 7 years of monitoring experience including > 1 years project management experience or equivalent combination of education, training and experience. (experience, 7 years)
- Advanced knowledge of job area, and broad knowledge of other related job areas, typically obtained through advanced education combined with experience. (experience)
- Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge; therapeutic knowledge desired. (experience)
- Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills. (experience)
- IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com (experience)
- IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. (experience)
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