Senior Manager, Clinical Operations

Convatec•Lexington, MA

51d•Hybrid

About The Position

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.

Requirements

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.).
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.
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.
Independently motivated, detail oriented and good problem-solving ability.
Excellent communication skills.
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
Speaking: Yes English
Writing/Reading: Yes English

Nice To Haves

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

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.
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.
Reviews site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments as needed
Coaches and provides guidance to clinical staff, will have management responsibilities for clinical trial management staff.