Clinical Research Manager, Immunology, Remote

Job description

Job Description This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with International Council for Harmonisation Good Clinical Practice (ICH-GCP) and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. The CRM could be responsible for a particular study for several countries in a cluster. Responsibilities include, but are not limited to: Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT). Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out. Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Reviews Monitoring Visits Reports and escalates performance issues and training needs to Clinical Research Associate (CRA) Manager and/or functional vendor and internal management as needed. Performs Quality control visits as required. Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports Clinical Research Associates (CRAs) as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the Clinical Trial Coordinator (CTC), CRAs and Clinical Operations Manager (COM)). Responsible for creating and executing a local risk management plan for assigned studies. Ensures compliance with Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF) and other key systems in assigned studies. Escalates as needed different challenges and issues to Therapeutic Area (TA) Head/Clinical Research Director (CRD)/Country Clinical Quality Manager (CCQM) and or CTT (as appropriate). Identifies and shares best practices across clinical trials, countries, clusters. Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies. Country POC for programmatically outsourced trials for assigned protocols. As a customer-facing role, this position will build business relationships and represent our Company with investigators. Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets). Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD, Therapeutic Area Head (TAH) and Regional Operations. Collaborates internally with Headquarters (HQ) functions, regional and local operations, European Union (EU) Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials. Consult with Global Human Health (GHH) as needed. Extent of Travel: Up to 30% of working time CORE Competency Expectations: Knowledge in Project Management and site management. Strong organizational skills with demonstrated success required. Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CRD. Requires strong understanding of local regulatory environment. Strong scientific and clinical research knowledge is required. Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously. Experience functioning as a key link between Country Operations and Clinical Trial Teams. Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions. Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery. Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication. Strategic thinking. Ability to work efficiently in a remote and virtual environment. Understand cultural inclusion. The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring. Behavioral Competency Expectations: Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our Company's Research Labs (CRL), Global Clinical Development (GCD) and Global Clinical Trial Operations (GCTO). Ability to identify problems, conflicts and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution is critical. Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include: 1) low patient recruitment 2) inadequate staff to meet business needs 3) performance or compliance issues 4) working with regulatory issues and the broader organization 5) resolution of conflictive situations. Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders. Experience Requirements: Required: 5+ years of experience in clinical research Preferred Experience: Clinical Research Associate (CRA) experience preferred Immunology experience preferred Trial management experience preferred Educational Requirements: Required: Bachelor's degree in science (or comparable) Preferred: Advanced degree (e.g., Master degree, MD, PhD) clinicaltrialjobs Required Skills: Adaptability, Clinical Research, Clinical Trials Operations, Decision Making, Good Clinical Practice (GCP), Quality Management, Regulatory Submissions, Risk Management, Strategic Planning, Strategic Thinking Preferred Skills: Clinical Study Management, Deliverables Management, Immunology, Leadership, Peer Mentoring Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s posi