[Hiring] Senior Manager, Clinical Data Management @Celcuity Inc.

Role Description

We are seeking a Senior Manager, Clinical Data Management who will report into the Executive Director, Clinical Data Management. You will focus on all aspects of the CDM process from project planning, the development of project documentation, system set-up, UAT through database lock. This person is a department-level contributor and may have oversight of junior CDM staff. The core duties and responsibilities of the Senior Manager, Clinical Data Management are delineated below.

Responsibilities:

Department Level:

• Responsible for timelines and quality of CDM deliverables for the assigned studies.
• Contributes to technical infrastructure of CDM such as not but limited to development of SOPs, departmental process improvement etc.
• Provides feedback and task assignment to meet department and company objectives.
• Supports budget and resource planning across assigned projects as required.
• Participates in CRO/vendor selection process for outsourced activities.
• Directs activities of direct reports as applicable.
• Participates in department or cross-functional initiatives as appropriate.

DM/Study Tasks:

• Represents CDM in study team meetings.
• Manages CDM timelines to coordinate and synchronize deliverables with the overall study timelines.
• Generates and/or reviews/approves study documents (e.g. study protocols, Data Management Plans, Case Report Forms, data transfer specifications, SAE/external data reconciliation plans, coding conventions).
• Oversight of CDM CRO/service providers (e.g. reviewing vendor SOPs, invoices).
• Monitors the progress of all CDM activities for the project to ensure project timelines are met.
• Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, and able to work independently towards the assigned goal.
• Performs duties as assigned by CDM management/Head of Department.

Qualifications

• Bachelor’s, or master’s degree (preferred) in Life Sciences, Computer Sciences, Mathematics, or health-related field.
• Minimum ten (10) years of DM experience in the pharmaceutical or biotechnology industry.
• Three (3) year of staff management desired.
• Demonstrated ability to pay attention to details and superior organizational skills.
• CRO management experience.
• In-depth knowledge of CDM principles, clinical trial process and regulatory requirements.
• Excellent verbal/written and interpersonal skills; able to communicate and collaborate effectively with cross-functional teams in a remote setting.
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
• Proven ability to work both independently and in a team setting.
• Experience with web-based Electronic Data Capture (EDC) preferably Medidata Rave, clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
• Prior oncology/hematology experience highly desirable.
• Ability to work in a team or independently as required.
• Outstanding organizational skills with the ability to prioritize.
• Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment.
• Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization.
• Flexible and willing to learn; adapting to business and site needs in a dynamic environment.
• Maintain a positive, approachable and professional attitude.

Benefits

• Anticipated base pay range is $175,000-$192,000 DOE.
• Eligible for an annual performance incentive bonus and a new hire equity package.
• Various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.

Company Description

Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth.

Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+/HER2- ABC in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going.