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Position Overview:

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com

At Convatec we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us as a Senior Clinical Study Manager (SCSM) and you’ll do the same.

The Senior Clinical Study Manager (SCSM) provides operational expertise to ensure the effective and efficient delivery of assigned clinical studies. As part of the Clinical Study Management pillar of Clinical Operations, Medical Affairs & Clinical Affairs (MACA), the SCSM is key in the successful delivery of clinical studies to support evidence needs across Convatec’s Business Units. Reporting to the Clinical Study Management Specialist, this role will ensure clinical study execution is timely, cost-effective and in accordance with Convatec’s policies and procedures, ISO, FDA and local regulations.

This is a remote US-Based role, seeking someone residing in the Eastern Time Zone

Key Responsibilities:

• Proactively manage assigned clinical studies.

• Effectively manage clinical study delivery across the Clinical Study team during study start-up, routine monitoring, and closeout activities, demonstrating enthusiasm and innovation.

• Identify and escalate clinical study risks and propose solutions for risk mitigation.

• Oversee clinical study finance tracking, identify and escalate potential risks.

• Provide regular progress reports for clinical study activities through ongoing tracking and review of study project plans.

• Coordinate the production of key clinical study documentation, including Clinical Investigation Plan (CIP), Investigator Brochure (IB), Informed Consent Form (ICF) and Clinical Study Report (CSR).

• Motivate a multi-disciplinary clinical study team.

• Drive milestone achievement through management of study issues and conflict resolution with limited oversight.

• Oversee 3rd party Vendors where necessary to support milestone achievement.

• Build and develop relationships with key internal teams, including Medical Affairs and Medical Writing.

• Support audit and inspection activities as needed.

• Update processes and SOPs, providing input in discussions around quality by design and operational delivery.

• Demonstrate Convatec's core values.

• May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives.

Authority (if applicable):

Ability to provide recommendations and suggestions to ensure delivery of assigned clinical study(s).

Skills & Experience:

• Strong knowledge of the clinical study lifecycle.

• Clinical study management skills, including the ability to manage timelines, budgets and resources effectively.

• Medical Device experience essential.

• Keen attention to detail.

• Advanced knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).

• Excellent collaborative team player.

• Experience in pre-market (IDE) and post-market clinical studies.

• Experience with Clinical Trial Management Systems.

Qualifications/Education:

• Bachelor’s or Master’s degree required, preferably in life sciences, medicine, or related discipline.

• Minimum of 10 years Clinical Research experience, preferably some within the medical device arena, with at least 5 years of experience in clinical study management. Years of experience may be considered in lieu of education.

Dimensions:

Principal Contacts & Purpose of Contact

Internal – Medical Affairs, Clinical Operations (Study Management, Site Management, Study Co-ordination, Data Analytics), Evidence Genertion, R&D

External – Vendors, Clinical Sites, Regulatory approvers (FDA, Competent Authorities, IRB/EC)

Travel Requirements

Position may involve travel up to 20% of the time, mostly domestic but some international travel may be required. Trips may include overnight travel.

Languages

• Speaking: Yes English

• Writing/Reading: Yes English

Working Conditions

Remote Working, however, occasional travel into the home office may be required.

Special Factors

Good working knowledge of Microsoft Suite including Office (Word,Excel,Powerpoint), Project, Teams

Flexibility to work across multiple time zones will be required.

Training will be provided at the Corporate, Department and Job Function level.

Our progress will give you countless opportunities to move forward too. Seek out new challenges, and you'll find them. Stretch your thinking, and you'll find new ways to make an impact. And if you embrace the opportunity to drive your own growth, you could go further, and achieve more, than ever before.

This is a big step forward.

This is work that'll move you.

#LI-LM1

#LI-Remote

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com .

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Already a Convatec employee?

If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!