Primary Function of Position As a Senior Manager of Clinical Affairs, this role is responsible for contributing to clinical strategies and overseeing study execution for emerging technologies across various specialties. Clinical trials in this portfolio may be both in the US and global and include first-human-use and pivotal clinical trials targeted for regulatory submission. This role will oversee and manages clinical protocols and other key study documents in support of regulatory submissions; manage clinical publications and evidence dissemination strategy, oversee manage communications with clinical trial sites, CROs, KOLs and medical societies; grow, develop and manage team to interface and support all clinical requirements of the company with the applicable guidelines and regulations; foresee challenges and develops critical concepts and methodologies to overcome those. As a functional manager, this role will also lead a team of clinical operations personnel, such as clinical study managers and clinical research associates and play a key role in their development. As a key cross-functional constituent, this employee will work closely with functions across the organization – Regulatory Affairs, R&D, Program Management Office (PMO), Clinical Research Engineering (CRE), Clinical Research Managers, Global Access Value Economics (GAVE), Global Public Affairs (GPA), Regulatory Compliance, Training, Legal, and commercial functions to optimize clinical study strategies to meet business objectives. Roles and Responsibilities Play a key role in the development of company’s strategy for clinical studies to meet business goals and objectives. Collaborate with internal stakeholders and KOLs to develop and review study concepts, protocol and study outlines and subsequently driving identified initiatives Acting as a key strategic partner to Regulatory Affairs to support regulatory approval of new products and contribute to clinical sections of regulatory submissions Responsible for managing resource and study budget to ensure clinical studies are conduced on schedule and within budget while ensuring high quality and compliance Build strong and sustaining relationship with investigational sites and investigators for ongoing and future studies Work closely with data management to provide guidance on development of case report form (CRF), data cleaning to ensure collection of high quality data Work closely with Biostats in study design, developing statistical analysis plan (SAP), analysis, interpretation and synthesis in order to develop Clinical Study Report and /or support development of scientific publications Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US FDA regulations and guidelines) and responsible for ongoing review of departmental procedures and process improvement initiatives Responsible for setting up effective goals that are meaningful to the department and impactful to the organizations Provide functional manager leadership to direct reports and provide ongoing guidance for the assigned team members in their internal/external communication and support direct reports in consistently achieving their goals and objectives Sets and hold individual and team accountable for high standard of competencies and overall performance Effectively distills complexity and provides clear and actionable direction and information, help team prioritize, solve complex problems that enable the team to make significant progress Develop talents, build a highly capable and effective team of clinical study managers (CSM) and clinical research associates (CRA) to efficiently manage clinical studies
Skill/Job Requirements Minimum Education: Bachelor’s or Master's degree in scientific field/MD/ PhD with 12+ years of professional experience and at least 3-5 years of supervisory experience is preferred Minimum of 5 years of experience independently managing clinical studies through different study phases (pre-IDE, IDE submission, site selection and activation, study execution, data analysis and study report, and closeout) Excellent clinical operation and project management skills, with strong experience collaborating or leading a cross-functional team Proven track record of strong cross-functional and key opinion leader management Strong experience with clinical study resource and budget management Strong experience supporting development of scientific and regulatory strategy for clinical studies Strong experience in developing study protocol and other study documents, conducting literature review, writing clinical section for regulatory submission Strong knowledge of 21 CFR part 812 , Good Clinical Practice, ISO14155 and other regulations/guidelines. Basic understanding of statistics, statistical methods, and design of experiment Previous experience supporting internal and external audit on clinical studies is preferred Excellent ability to interact with physicians and other professionals