Associate Clinical Research Manager

General Description: 

• Accountable for regional/country study delivery (depending on the assignment) or specific aspects hereof with appropriate inspection readiness quality, within agreed timelines and budget 

• Manages the regional/country clinical operations team (incl oversight of external partners working on the regional/country level) and acts as point of escalation for the resolution of issues within the region/country for the assigned study, or supports the Senior Clinical Study Manager with specific aspects of regional/country study delivery 

• Ensures alignment of regional/country deliverables with overall study goals  

Essential Functions of the job:  

Regional/Country Leadership 

• Manages the regional/country 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 or drives specific aspects of regional/country study delivery in collaboration with the Senior Clinical Study Manager  

• Leads external vendors involved in study delivery on a regional/country level 

• Collaborates with key stakeholders in the region/country and provides regular updates on study progress in the region/country to senior management and Global/Region-focused Clinical Study Manager as needed 

• Can represent the regional/country study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings as applicable 

• May lead regional/country operations meetings with all regional/country study team members 

Timelines, Planning and Execution 

• Manages planning and management of the assigned clinical study(ies) or specific activities from feasibility through closeout activities for region/country, in line with global/regional study timelines 

• Generates, manages, and maintains high-quality study start-up and recruitment timelines for the region/country and tracks progress towards these 

• Ensures that the clinical study is operationally feasible in the region/country, manages trial feasibility, country allocation and site selection process for the assigned region/country in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders 

• Provides regional/country input on global/regional study plans as required 

• Ensures the timely availability of local adaptations of global/regional study documents, such as informed consent forms, in close collaboration with other key stakeholders to ensure timely submission to regulatory authorities and ECs/IRBs 

• Accountable for submissions of study in assigned region/countries in close collaboration with regional/country study start up team and regulatory affairs 

• Ensures regional/country information in study systems and tools is entered and up to date  

•     Collaborates closely with CRAs in the region/country to ensure proper study execution at the sites. Reviews and signs-off on monitoring reports 

• Responsible for working with regional/country teams to ensure that country and site level Trial Master File is created, maintained and QC’d regularly as per the study TMF QC Plan 

• Provides input to Global Clinical Supplies regarding drug inventories in the region/country and reviews local drug labels for the region/country. Provides input on local regulatory approval and reimbursement status of comparator drugs used in the study for the assigned region/country 

• Manages the trial data collection process for the region/country, drives data entry and query resolution 

• As required, supports planning and execution of the Clinical Study Report in collaboration with Global/Region-focused Clinical Study Manager and Medical Writing 

Quality: 

•     Handles escalated issues or problems with the sites in the region/country in close collaboration with stakeholders such as country heads 

• Monitors study activities in region/country to ensure compliance with study protocol, SOPs, ICH/GCP, and all other relevant regulations 

• Ensures inspection readiness for study in the region/country at any point in time throughout the study life cycle 

• Informs Global/Region focused Clinical Study Manager of any issues arising on the study, evaluates the impact and ensures solutions are implemented 

• Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate 

• Collaborates with CST members and colleagues to ensure cross-team, site learnings, and best practices are shared 

• Leads improvements and partners with CST members to enhance the efficiency and the quality of the work performed on assigned studies 

Budget and Resources 

• Works with the sourcing team to select and manage regional/country study vendors 

• Manages regional/country study budgets 

• Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities 

• Identifies and manages regional/country team resource needs and establishes contingency plans for key resources 

• Monitors regional/country resource utilization over study life cycle and liaises with functional managers as needed 

Supervisory Responsibilities:   

• Provides performance feedback on team members as required