About Convatec
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 more than 10,000 colleagues, we provide our products and services in around 90 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. Convatec's revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com
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 more than 10,000 colleagues, we provide our products and services in around 90 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. Convatec's revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com
Position Overview:
The Sr. Manager, Clinical Operations plays a key role to the success of Convatec's clinical trials. The Sr. Manager, Clinical Operations oversees the management of the day-to-day operations of clinical trials, ensuring they are conducted efficiently, effectively, and in compliance with all relevant regulations including ICH GCP guidelines, local regulatory requirements, and Convatec's policies and SOPs.
Key Responsibilities:
Working closely with Clinical Study Managers (CSMs) and Clinical Research Associates (CRAs), manage all operational aspects from start-up to close-out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance with applicable SOPs, guidelines, and regulations.
Working closely with the Global Head of Clinical Operations, develop study level operational strategy and clinical operations plans in support of execution of the Clinical Portfolio.
Working closely with CSMs, manage invoice and budget tracking for individual studies and provide input into budget forecasting activities.
Support the selection, oversight, and management of Clinical Research Organizations (CROs) and other vendors for clinical studies that are outsourced to third party vendors (with the exception of data management / data analytics as this service would be managed by Convatec's Manager, Data Management & Analytics.
Monitor and assess vendor performance against contractual operational deliverables.
Drive performance, quality, timelines, and relationships in partnership with the CRO and other vendors.
Provide oversight of study scope, quality, timelines, and budget with the internal functional leads, CRO and vendors to ensure project objectives remain on track.
Participate in a site engagement program to build solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and other activities.
Responsible for planning and conducting investigator meetings together with the CRO or Convatec meeting event planner.
Partner with the CRO or lead CRA and CSM to ensure patient enrollment strategies are conducted effectively and on time.
Participate in proactive data monitoring activities with the lead CRA to ensure quality and completeness of study data.
Evaluate issues and suggest and implement solutions and mitigation as required.
Create appropriate risk assessments and mitigation plans, perform regular reviews to continually assess changing circumstances.
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate.
May independently manage Convatec clinical studies as needed.
Skills & Experience:
Key competencies and characteristics candidates need to demonstrate to help build our diverse, inclusive culture and to be successful in this role include:
Strong clinical study management skills
Communication skills
Problem solving, conflict resolution, leadership and team building skills.
Excellent organizational and time management skills.
Engage and motivate teams
Qualifications/Education:
Bachelor degree in a scientific or health related discipline. Advanced scientific or business degree or equivalent experience desirable.
Minimum of 8 to 10 years of clinical trial management experience in conducting and leading global medical device clinical trials, preferably with a sponsor company.
Solid understanding of the device development process, ICH guidelines/GCP and specifically, each step within the clinical trial process, US/EU patient data privacy laws.
Demonstrated ability to lead teams in a fast-paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously.
Ability to successfully engage and work collaboratively with cross functional team members including, but not limited to, regulatory, R&D, project/program management, data management, and medical monitors.
Daily interaction with clinical study managers, clinical research associates, data management and other members of the cross-functional study team; frequent cross-functional interactions with internal and external personnel (e.g., , investigators, CROs, vendors, etc.).
Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws, while maintaining clear instructions for procedures and activities to the achievement of company goals.
Enjoy building relationships with KOLs and site personnel with a willingness to travel to establish and build relationships.
Experience in vendor selection and overseeing studies being managed by a CRO.
Reviews site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments as needed
Strong understanding of clinical study budgets, accruals, and forecasting.
Participates in site initiation, monitoring and close out visits as appropriate.
Demonstrated ability to solve problems and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
Coaches and provides guidance to clinical staff, will have management responsibilities for clinical trial management staff.
Independently motivated, detail oriented and good problem-solving ability.
Excellent communication skills.
Experience in wound care, ostomy, and / or incontinence is a plus.
Dimensions:
Team
This position will have ~8 direct reports (contract and full-time Convatec CSMs).
Principal Contacts & Purpose of Contact
Internal - Medical Affairs, Clinical Operations (Study Management, Site Management, Data Management / Data Analytics), Global Head of Clinical Operations, R&D, Regulatory and executive leadership as needed
External - Vendors, Clinical Site Staff, KOLs / site investigators, Lead PIs, IRBs/ECs
Travel Requirements
This position will require up to 30% of travel, mainly within the USA. International travel may also be required at times but should not exceed 2-3 times a year.
Languages
Speaking: Yes English*
Writing/Reading: Yes English*
Working Conditions
Remote Working (2 days in office if candidate is located in Massachusetts)
Special Factors
Working hours will require some overlap with headquarters in Deeside,UK (GMT+0 in winter and GMT+1 In
summer)
Ready to join us?
At Convatec, we're pioneering trusted medical solutions to improve the lives we touch. If you're ready to make a real impact, apply today and help us bring our Forever Caring promise to life.
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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.
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