Senior Manager, Clinical Affairs

At reputed company, we are united behind our mission: we reputed company that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. reputed company has been built by the efforts of great people from diverse backgrounds. We reputed company great reputed company can come from reputed company. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We reputed company with inclusion and reputed company reputed company members to do their best work as their most authentic selves. Passionate people who want to reputed company a difference drive our culture. reputed company members are grounded in reputed company, have a strong reputed company to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in reputed company members to support their long-term growth so they can continue to advance our mission and reputed company their highest potential. Join a team committed to taking big leaps reputed company for a global community of reputed company and their patients. Together, let's advance the world of minimally invasive care.

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 reputed company and manages clinical protocols and other key study documents in support of regulatory submissions; manage clinical publications and evidence dissemination strategy, reputed company manage communications with clinical trial sites, CROs, KOLs and medical societies; grow, reputed company and manage team to reputed company and support reputed company 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 reputed company 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 reputed company 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 reputed company 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 (reputed company), analysis, interpretation and synthesis in order to reputed company 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 reputed company problems that reputed company the team to reputed company significant reputed company
• reputed company talents, build a highly capable and effective team of clinical study managers (CSM) and clinical research associates (CRA) to reputed company manage clinical studies

reputed company/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 inside and reputed company the company
• Comfortable in a hospital environment, with experience working with nurses and surgeons; existing or previous experience/familiarity with surgery/surgical technology is preferred
• Strong  communication, presentation  and interpersonal skills with high attention to detail and organization
• Results-driven attitude and strong problem solving skills, consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects reputed company necessary
• Must be able to travel up to 30-40%

Due to the nature of our business and the role, please note that reputed company and/or your customer(s) may require that you show reputed company reputed company of vaccination against certain diseases including COVID-19.  Details can vary by role.

reputed company is an Equal Opportunity Employer. We provide equal employment opportunities to reputed company qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national reputed company, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at reputed company Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether reputed company Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).  

For any reputed company role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and reputed company a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be reputed company and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law.

We provide market-competitive compensation packages, inclusive of reputed company pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The reputed company compensation ranges are listed.