Convatec
Associate Director, Clinical Trials Management
Convatec, Lexington, Massachusetts, United States, 02173
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Senior Manager, Clinical Operations
role at
Convatec Direct message the job poster from Convatec Overview
The Sr. Manager, Clinical Operations plays a key role in the success of Convatec’s clinical trials. The role oversees the day-to-day management of clinical trial operations to ensure studies 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
Work closely with Clinical Study Managers (CSMs) and Clinical Research Associates (CRAs) to manage all operational aspects from start-up to close-out, ensuring adherence to timelines, budget and milestones while complying with SOPs, guidelines, and regulations. Collaborate with the Global Head of Clinical Operations to develop study-level operational strategy and clinical operations plans in support of the Clinical Portfolio execution. Manage invoice and budget tracking for individual studies and contribute to budget forecasting. Support selection, oversight, and management of CROs and other vendors for outsourced studies (excluding data management / analytics, managed by Convatec’s Manager, Data Management & Analytics). Monitor and assess vendor performance against contractual deliverables; drive performance, quality, timelines, and relationships with CROs and vendors. Provide oversight of study scope, quality, timelines, and budget with internal leads, CROs, and vendors to keep project objectives on track. Participate in site engagement to build relationships with key opinion leaders and site staff to support enrollment and trial activities. Plan and conduct investigator meetings with CRO or Convatec event planners as needed. Partner with CROs or lead CRA and CSM to ensure effective patient enrollment strategies. Participate in proactive data monitoring with the lead CRA to ensure data quality and completeness. Evaluate issues, implement solutions, and create risk assessments and mitigation plans with regular reviews of changing circumstances. Review and provide clinical operations input into relevant documents (protocol, Investigator’s Brochure, regulatory documents, clinical study reports, and related plans). May independently manage Convatec clinical studies as needed. Skills & Experience
Strong clinical study management skills Excellent communication and problem-solving abilities, including leadership and team-building Excellent organizational and time management skills Ability to engage and motivate cross-functional teams Qualifications/Education
Bachelor’s degree in a scientific or health-related discipline; advanced degree or equivalent experience desirable 8–10 years of clinical trial management experience in global medical device trials, preferably with a sponsor company Solid understanding of device development, ICH/GCP, and US/EU patient data privacy laws Ability to lead in a fast-paced, matrixed environment; prioritize multiple tasks Ability to collaborate with regulatory, R&D, project management, data management, and medical monitors Experience with SOP development and compliance; willingness to travel to build relationships with sites and KOLs Experience in vendor selection and CRO oversight; familiarity with site documentation and contracts; budget, accruals, and forecasting knowledge Participates in site initiation, monitoring, and close-out visits as appropriate Coaches and mentors clinical staff; management responsibilities for clinical trial management staff 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). Travel, Languages & Working Conditions
Travel up to 30% (primarily within the USA); international travel may occur 2–3 times per year. Languages: English (speaking, writing, reading). Working conditions: Remote work with 2 days in the office if located in Massachusetts. Special Factors
Some overlap with Convatec headquarters (Deeside, UK) hours. Some roles require coordination across different time zones. 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. EEO & Compliance
Equal opportunities: Convatec provides equal employment opportunities for all current employees and applicants. This policy prohibits discrimination on race, religion, creed, color, national origin, sex, age, disability, sexual orientation, gender identity, military status, or any other basis prohibited by law. Notice to Agencies: Convatec does not accept unsolicited resumes from agencies or search firms. Resumes submitted without a signed search agreement will become the property of Convatec. No fee will be paid for unsolicited referrals. Already a Convatec employee? If you are an active employee, please use the internal Career site to apply. Location: Lexington, MA
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Senior Manager, Clinical Operations
role at
Convatec Direct message the job poster from Convatec Overview
The Sr. Manager, Clinical Operations plays a key role in the success of Convatec’s clinical trials. The role oversees the day-to-day management of clinical trial operations to ensure studies 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
Work closely with Clinical Study Managers (CSMs) and Clinical Research Associates (CRAs) to manage all operational aspects from start-up to close-out, ensuring adherence to timelines, budget and milestones while complying with SOPs, guidelines, and regulations. Collaborate with the Global Head of Clinical Operations to develop study-level operational strategy and clinical operations plans in support of the Clinical Portfolio execution. Manage invoice and budget tracking for individual studies and contribute to budget forecasting. Support selection, oversight, and management of CROs and other vendors for outsourced studies (excluding data management / analytics, managed by Convatec’s Manager, Data Management & Analytics). Monitor and assess vendor performance against contractual deliverables; drive performance, quality, timelines, and relationships with CROs and vendors. Provide oversight of study scope, quality, timelines, and budget with internal leads, CROs, and vendors to keep project objectives on track. Participate in site engagement to build relationships with key opinion leaders and site staff to support enrollment and trial activities. Plan and conduct investigator meetings with CRO or Convatec event planners as needed. Partner with CROs or lead CRA and CSM to ensure effective patient enrollment strategies. Participate in proactive data monitoring with the lead CRA to ensure data quality and completeness. Evaluate issues, implement solutions, and create risk assessments and mitigation plans with regular reviews of changing circumstances. Review and provide clinical operations input into relevant documents (protocol, Investigator’s Brochure, regulatory documents, clinical study reports, and related plans). May independently manage Convatec clinical studies as needed. Skills & Experience
Strong clinical study management skills Excellent communication and problem-solving abilities, including leadership and team-building Excellent organizational and time management skills Ability to engage and motivate cross-functional teams Qualifications/Education
Bachelor’s degree in a scientific or health-related discipline; advanced degree or equivalent experience desirable 8–10 years of clinical trial management experience in global medical device trials, preferably with a sponsor company Solid understanding of device development, ICH/GCP, and US/EU patient data privacy laws Ability to lead in a fast-paced, matrixed environment; prioritize multiple tasks Ability to collaborate with regulatory, R&D, project management, data management, and medical monitors Experience with SOP development and compliance; willingness to travel to build relationships with sites and KOLs Experience in vendor selection and CRO oversight; familiarity with site documentation and contracts; budget, accruals, and forecasting knowledge Participates in site initiation, monitoring, and close-out visits as appropriate Coaches and mentors clinical staff; management responsibilities for clinical trial management staff 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). Travel, Languages & Working Conditions
Travel up to 30% (primarily within the USA); international travel may occur 2–3 times per year. Languages: English (speaking, writing, reading). Working conditions: Remote work with 2 days in the office if located in Massachusetts. Special Factors
Some overlap with Convatec headquarters (Deeside, UK) hours. Some roles require coordination across different time zones. 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. EEO & Compliance
Equal opportunities: Convatec provides equal employment opportunities for all current employees and applicants. This policy prohibits discrimination on race, religion, creed, color, national origin, sex, age, disability, sexual orientation, gender identity, military status, or any other basis prohibited by law. Notice to Agencies: Convatec does not accept unsolicited resumes from agencies or search firms. Resumes submitted without a signed search agreement will become the property of Convatec. No fee will be paid for unsolicited referrals. Already a Convatec employee? If you are an active employee, please use the internal Career site to apply. Location: Lexington, MA
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