Sr. Clinical Study Manager

**Why join Stryker?**:
Our total rewards package offering includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards - not to mention various social and recreational activities, all of which are location specific.

**Know someone at Stryker?**:
**_What are we looking for : _**

**Meticulous documenters.** Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

**Strategic thinkers. **People who enjoy analyzing data or trends for 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 improvements across the business.

**_ Why should you join us?_**

We offer you the opportunity to develop your career by capitalizing on your strengths. Stryker recruits and develops committed, passionate and talented individuals, motivated by innovation, growth and opportunity. We develop talent

**_ We offer:_**
- Teamwork, commitment and integration
- Recognition of individual and collective performance
- Flat hierarchies and responsibilities
- Competitive and progressive salary and benefits

As our future Senior Clinical Study Manager you will manage multiple aspects of clinical operations for assigned clinical trials/product lines (**mainly neurovascular**) to assure the highest standards of clinical study execution with guidance from Senior Lead CPM or Program Manager.
- You will execute and develop a project plan including management of schedule, cost, resources, and deliverables (e.g., protocol, database development, reporting).
- You will manage the planning and communication with cross-functional teams to ensure proper execution and conduct of the trial.
- You will be the primary contact and resource for Lead CRA, CRO and vendor personnel, supporting selection and providing oversight and management of CROs, consultants and vendors.
- You will track and report on the progress of assigned clinical trials including budget and timelines.
- You will collaborate and work with Clinical Trial Managers, Data Managers, Clinical Trial Assistants and Document Control Specialists to create and manage study related documents.
- You will maintain up to date knowledge of published literature in relevant therapeutic areas including a broad awareness of neurovascular issues.
- You will co-monitor with CRO’s Monitors to evaluate and ensure quality of the CRO Monitoring Team. Ensuring that studies are conducted in accordance with the protocol, GCP / ICH guidelines, EU regulations and department SOPs.
- You will organize (or assists with organizing) and participate in meetings - i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops, and CRO Training.
- You will assist in the preparation of regulatory documents including notified bodies and IRB annual updates, briefing documents, CTAs, as requested.
- You will develop and maintain positive relationships both with internal and external partners of the project, including site personnel (KOLs, PIs, Study coordinators).
- You will proactively identify risks and lead team members to mitigate risks in timely fashion.
- You will fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to, being current on all training requirements for the incumbent's position and documenting that training).

**_ Your profile _**
- You have a bachelor's level degree or equivalent in a health/science related field.
- You have **4+ years of experience as Project Manager **or Senior CRA (In House) in **pre-market and post-market clinical trials** (project leadership, vendors management, CROs studies or contractors management).
- You are a Certified Clinical Research Associate (CCRA certification) (preferred).
- You demonstrate a working knowledge of GCP, ICH guidelines, and EU regulations.
- Ideally, you have experience monitoring **medical device **studies.
- You are proficient in resource planning and financial management (clinical trial budgeting) required.

**_ Who you are _**
- You are passionate by science, medical devices, and research This role is for Clinical Trial Experts in the neurovascular environment that are driven to make healthcare better
- You are well organized and detail oriented.
- You work effectively in a team or independently on assigned tasks

**_ What do we offer in return?_**

We grow talent; we give you the opportunity to develop your career based on your strengths. Stryker is a career destination for engaged passionate and talented people who are driven to seek the innovation, growth and opportunity that only we offer.
- Flat hierarchies and responsibility: through flat hierarchies, we strengthen the initiative and willingness of our emp