Apply on Employer Site

Convatec · 2 days ago

Senior Manager, Clinical Trials Management

Lexington, MA

Full-time

Hybrid

Senior Level, Lead/Staff

8+ years exp

Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions. The Senior Manager, Clinical Trials Management oversees the operations of clinical trials, ensuring compliance with regulations and effective management of study activities.

Clinical TrialsHealth CareManufacturingMedical

Hiring Manager

Kelly McCluskey

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

Qualification

Clinical trial managementICH guidelines/GCPVendor managementBudget forecastingTeam buildingWound care experienceProblem solvingCommunication skillsLeadership skillsOrganizational skills

Required

Bachelor degree in a scientific or health related discipline

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

Preferred

Advanced scientific or business degree or equivalent experience desirable

Experience in wound care, ostomy, and / or incontinence is a plus

Company

Convatec

Glassdoor3.4

ConvaTec specializes in the development, manufacture, distribution of single-use devices to hospitals and healthcare sectors. It is a sub-organization of The Amcare™ Group.

Founded in 1978

Reading, Reading, GBR

5001-10000 employees