Senior Manager, Clinical Operations

Sr. Manager, Clinical Operations

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 :

Qualifications / Education :

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

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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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.

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