Clinical Affairs Professional

Job Description

Clinical Affairs Professional

Who we want

• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do

As the Clinical Project Manager, you will assist in the strategic study design, planning and execution of clinical trials while adhering to budget, scope and timelines. You will support the development of trial pathways for current and new products globally. You will also manage multiple aspects of clinical operations to ensure the highest standards of clinical study execution with guidance from Senior Clinical Research Manager. You will collaborate with cross functional teams (clinical, divisional, and external) and acts as Corindus liaison with site investigators and study coordinators to conduct quality research and generate clinical evidence.

• Lead the completion of clinical supporting documentation and strategic justifications needed to support successful regulatory submissions globally (e.g. no clinical trial needed, label expansion)

• Communicate with cross-functional teams to ensure proper execution and conduct of the trial.

• Serve as primary contact and resource for Lead CRA, CRO and vendor personnel.

• Supports selection and provides oversight and management of CROs, consultants and vendors.

• Track and reports on the progress of assigned clinical trials including budget and timelines.

• Execute a project plan including management of schedule, cost, resources and deliverables (e.g. protocol, database development, reporting).

• Develop project plans and ensures adherence to budget and timelines

• Work with cross functional teams to create and manage study related documents.

• Work closely with clinical core team to ensure quality of clinical trial data

• Maintain up to date knowledge of published literature in relevant therapeutic areas including a broad awareness of neurovascular issues

• Co-monitor with CRO’s Monitors to evaluate and ensure quality of CRO Monitoring Team. Ensures that studies are conducted in accordance with the protocol, GCP/ICH guidelines, FDA regulations and department SOPs.

• Organize (or assists with organizing) and participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops, and CRO Training.

• Assist in preparation of regulatory documents including IDEs, IDE and IRB annual updates, briefing documents, CTAs, as requested

• Assist in the development of in-house operations SOPs, guidelines and systems

• Develops and maintains positive relationships both internal and external to project, including site personnel (KOLs, PIs, Study coordinators).

• Demonstrate thorough knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable Stryker SOPs and policies

• Proactively identifies risks and leads team members to mitigate risks in timely fashion

• Oversees data clarification process as needed in conjunction with selected CRO and insure database lock according to agreed timeline

• Input/prepare patient informed consent forms (ICFs)

• Triage CRO and clinical site questions as appropriate

• Prepare and manages clinical trial site budgets

What you need

• A minimum of a bachelor’s degree (B.S. or B.A.) or experience as a Medical Healthcare Professional required.

• Proficiency in resource planning and financial management (clinical trial budgeting) required.

• A minimum of 5 years of experience in a Clinical Research capacity required.

• Certified Clinical Research Associate (CCRA certification) preferred.

• Project Management Professional Certification preferred.

• Must have a demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.

• Well organized and detail oriented, strong written and verbal communication skills.

• Experience monitoring medical device studies preferred.

• Previous Medical Device experience required.

• Experience with global regulatory submissions preferred.

• Effective process and project management skills.

• Previous experience within a Sponsor organization or a Clinical Research Organization required.

• Previous experience in a Clinical Operations role required.

• Demonstrated problem solving abilities in overseeing clinical studies working with external CROs preferred.

Organization: Siemens Healthineers

Company: Corindus, Inc.

Experience Level: Mid-level Professional

Job Type: Full-time

Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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