Manager Clinical Operations

1 month ago

Nashua, United States Conformal Medical Full time

Title: Manager Clinical Operations (East)

Location: Nashua, NH (Preferred)


Company

Join an innovative, rapidly expanding, clinical-stage medical device company and be part of something revolutionary


Conformal Medical, Inc. is a medical device company based in Nashua, NH. The company is focused on developing advanced technology for left atrial appendage occlusion (LAAO), a rapidly growing field in cardiovascular medical technology. Recently, the company completed its Series D financing, raising $35 million. The funding will support iterative development projects, broaden clinical experience in expanded geographies, and drive the CONFORM Pivotal Trial. This trial, currently on hold, aims to assess the CLAAS® device compared to other commercially available LAAO devices in patients with non-valvular Afib. The company plans to improve the product and resume enrollments later this year.


Join us as we continue our journey to bring CLAAS technology to the US and beyond.

The Senior Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing. Strong leadership and vendor management is critical for this role. The position reports to the Vice President, Clinical. This role may work collaboratively on one trial or across several trials to support clinical operations activities.


Responsibilities

•Independently manage the full scope of study conduct (start-up through database lock) and coordinating cross-functional efforts to achieve study objectives and goals and for collaborating with the clinical team, Clinical Program Leader, and others to meet Corporate Goals.

•Lead internal cross-functional study execution team for assigned studies to identify risks and mitigations strategies.

•Lead preparation of vendor requirements and project scope, selection of study vendors and oversight of clinical research organizations to ensure timely and quality deliverables.

•Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per FDA IDE guidance.

•Oversee the quality of the clinical trial master files and the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans.

•Author, audit and/or edit presentations, training material, and study documents .

•Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members; create and conduct study-specific training at investigator meetings.

•Review study invoices and participate in accrual reviews to track the financial status of the study against budget.

•All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs.

•Work with cross-functional sections/teams to deliver clinical study projects under the constraints of study scheduling and resources.

•Strive for continuous improvement and more efficient ways of working in clinical development


Qualifications

•Bachelor’s degree required. RN/PA with professional clinical experience, and/or Master’s degree or higher in health-related science or equivalent preferred.

•7+ years in a Medical Device sponsor side experience with 5+ years of trial management experience required.

•Excellent organizational skills and attention to detail.

•Effective communication and interpersonal skills.

•Ability to efficiently perform multiple tasks and manage changing priorities.

•Good project management skills

•Ability to identify and solve logistical problems.

•Demonstrate proficiency in Microsoft Word, PowerPoint and Excel.

•Ability to build strong relationships with co-workers of various backgrounds and expertise.

•Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.

•Travel is variable and potentially up to 50% during peak periods


See Conformal’s website for more information:

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