Manager, Clinical Affairs, Akura Medical

Our team shares a passion for developing innovative medical
technologies that improve patients’ lives. If you are seeking a
dynamic environment where you can make a real impact,
Shifamed is a good fit for you.

Location: Campbell, CA

Job Id:383

# of Openings:0

Akura Medical, a Shifamed Portfolio Company, is focused on a differentiated approach delivering an effective solution to address the major challenges of venous thromboembolism (VTE). Akura recently announced the first-in-human use of its mechanical thrombectomy platform. Each year VTE affects as many as 900,000 Americans, resulting in about 100,000 premature deaths. To learn more about Akura Medical, please visit www.akuramed.com.

ABOUT SHIFAMED

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

Description

The Manager, Clinical Affairs will be responsible for input, conduct and implementation of clinical trials (IDE). The candidate will be integral throughout the lifecycle of the project and liaise with internal team members and external clinical sites, investigators, consultants, andvendors involved in study execution. This individual is responsible for the execution of the clinical trial to meet the overall development strategy and ensure that clinical trials are conducted in a timely fashion and meet company goals and budgets. This role will oversee work performed by Contract Research Organizations (CROs) and other vendors. This role will report to the VP of Clinical Affairs. This is a 100% onsite position.

Responsibilities, Skills & Hands-On Experience:

Clinical Trial Execution and Oversight

• Responsible for implementation of clinical development plans by managing timelines, budgets, and resource requirements.
• Responsible for the development and content of risk mitigation plans to ensure clinical trials are on time and within budget.
• Ensure successful implementation of clinical trial operational plans ensuring that clinical trials are conducted in a timely fashion and compliant with SOPs, GCP, and regulatory guidelines, company goals, and budgets, working collaboratively with the clinical operations group and cross- functional team.
• Responsible for the preparation of Clinical Protocols, Investigator's Brochures (IBs), Case Report Forms (CRFs), Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs).
• Leads CROs/vendors selection process for outsourced activities, including the development of scope of services agreements, budgets, plans, and timelines.
• Manages CRO/vendor agreements, operational plans, budgets, and work known to be performed by CROs/vendors.
• Liaise with CROs/vendors to ensure study execution and deliverables are being met.
• Participates in patient recruitment activities and the development of patient recruitment plans and backup plans, e.g., by liaising with patient advocacy organizations.
• Identifies, recruits, and develops relationships with clinical investigators and site staff in collaboration with Medical Monitor and Clinical Operations leadership.
• Oversight of contract and budget negotiations with clinical sites.
• Ensures that all supportive study-related documents are completed (e.g., Monitoring Plan, Study Reference Manual, Laboratory Manual, Pharmacy Manual, Source/CRFs, including electronic documents.
• Ensures that all monitoring activities and processes are complete, including training of internal and external resources, and are compliant with SOPs, GCP, and regulatory guidelines, company goals, and budgets.
• Development/coordination of study training for the study team, investigational sites, and vendors including oversight of required country regulatory (e.g., CTA, MoH) and country/site IRB/IEC/approvals.
• Responsible for inputs into the regulatory plans and user testing as needed.

Build Operational Infrastructure

• Partner with the VP of Clinical Affairs to develop staff, structure the department, and create a highly desired work environment for attracting and retaining highly qualified clinical operations professionals.
• Build, manage, and nurture clinical operations staff and direct reports.
• Develop and ensure compliance with company SOPs and guidelines, FDA regulations, and current ICH GCP guidelines.
• Evaluate and analyze tools and processes to support outsourcing efforts.
• Work with the clinical team to identify and develop innovative systems that enhance clinical trials, clinical program management, and/or department efficiency. Interface effectively with other groups within the organization.
• Work with senior management to develop and achieve corporate goals and work with clinical staff to achieve the established corporate goals within the expected time frames.
• Act as a key resource to provide financial information related to clinical development and manage trials costs.

Education & Work Experience

• BA/BS degree or higher, preferably in life sciences.
• Minimum of 8+ years of clinical operations experience with a thorough understating of cross- functional processes, including clinical supply and data management.
• At least 4 years of clinical operations line management experience.
• Strong knowledge of Good Clinical Practices and ICH guidelines and their application to the conduct of clinical trials.
• High proficiency in clinical studies involving complex design issues (e.g., multiple arms, crossover, double-blind, and multi-center) in all phases of pre-approval clinical trials.
• Strong analytical and problem-solving skills.
• Proven ability to provide scientific and clinical expertise to a clinical development program.
• Maintain a high level of professional expertise through familiarity with industry trends, new regulations, and clinical literature.
• Must be a demonstrated self-starter and team player with strong interpersonal skills.
• Must have the ability to build and maintain positive relationships with management, peers, and subordinates.
• Excellent written and verbal skills required.
• Must display strong analytical and critical thinking skills.

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $115,000 to $150,000 + equity + benefits.

NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.

Note: Principals only. No third party referrals will be accepted without prior approval by Shifamed. As a general practice, Shifamed does not accept unsolicited resumes or placement information from any individual or agency that supplies candidates for a fee.

This link leads to the machine-readable files that are made available in response to the federal Transparency in Coverage Rule and includes negotiated service rates and out-of-network allowed amounts between health plans and healthcare providers. The machine readable files are formatted to allow researchers, regulators, and application developers to more easily access and analyze data.