Clinical Study Manager

Smith & Nephew - Remote (30+ days ago)3.7


ABOUT US

Smith & Nephew supports healthcare professionals in more than 100 countries in their daily efforts to improve the lives of their patients. We do this by taking a pioneering approach to the design of our advanced medical products and services , by securing wider access to our diverse technologies for more customers globally, and by enabling better outcomes for patients and healthcare systems.

We have leadership positions in:
Orthopaedics Reconstruction - joint replacement systems for knees, hips and shoulders
Advanced Wound Management - wound care treatment and prevention products used to treat hard-to-heal wounds
Sports Medicine - minimally invasive surgery of the joint
Trauma & Extremities - products that help repair broken bones
We have around 16,000 employees around the world. Annual sales in 2016 were more than $4.6 billion . We are a constituent of the UK's FTSE100 and our shares are traded on the London Stock Exchange and through American Depository Receipts on the New York Stock Exchange (LSE: SN, NYSE: SNN)

SUMMARY

Conduct clinical studies to support regulatory submissions and post market surveillance of Smith & Nephew products. Conduct observational studies. Ensure adherence to Good Clinical Practices and applicable regulations, standard operating procedures, Smith & Nephew Code of Conduct, and study protocols in accordance with established budgets and timelines.

ESSENTIAL FUNCTIONS

With supervision, assess study feasibility, contribute to study design elements, and collaborate with Clinical Strategy Lead and project team to develop protocols for clinical studies.
Support training investigators, research coordinators, Contract Research Organizations (CROs), central laboratories, and other study vendors on study related procedures. Support providing first tier support for protocol, SOPs, and systems.
With supervision, plan, manage, and report all aspects of global clinical studies through oversight of cross-functional study activities.
With supervision, create and report clinical study updates to management on a regular basis; report on performance to plan.
Coordinate and oversee clinical studies to support regulatory submissions (IDE, PMA, 510(k) and Post Market Surveillance); assist in preparation of clinical study reports, regulatory documents and submissions as directed.
With supervision, liaise with ASD product teams and in country sales and marketing personnel to ensure effective study alignment with product strategy throughout the design, implementation and lifetime of the clinical study.
Independently monitor, and/or assist CRAs with monitoring activities, to ensure compliance with study protocols, regulatory requirements, and Smith & Nephew procedures.
Follow current SOPs. May assist in the evaluation of current procedures for efficiencies and quality as well as make recommendations to management for improvements.
Independently organize and lead internal and external meetings with associated communications and materials.
With supervision, contribute to scientific publications in international peer-reviewed journals and other publications, conferences, and other media as appropriate.
REQUIREMENTS

TRAVEL: Domestic and International up to 25%

EDUCATION: Bachelor’s Degree in life sciences or related field or equivalent education and experience

LICENSES/CERTIFCATIONS : CCRP or CCRA certification desired

EXPERIENCE : Minimum 2-5 years’ experience in medical device industry, clinical setting or research field

COMPETENCIES:
Study Management/Project Management skills - demonstrates understanding and quality delivery of study milestones according to established timelines
Ability to handle complex projects/problems
Ability to identify investigational sites and investigators
Strong negotiation and professional communication skills - strong oral and written English
Advanced knowledge and application of industry standards and best practices in clinical data management and applicable country regulations (US FDA, ISO, ICH, etc.)
Attention to detail
Product and indication/disease knowledge, understanding basics of surgical procedures
Contribute to design teams and clinical development plans for lifecycle of product.
SUPERVISION: Requires general supervision and oversight

OTHER:
Experience with Microsoft Excel, Word, PowerPoint, Outlook, SharePoint, Project and Visio
Experience with Clinical Trial Management Systems, Trial Master File Systems, and Electronic Data Capture.
Smith and Nephew is an Equal Opportunity/Affirmative Action Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by applicable law.