Senior Clinical Trial Associate

Our Mission:

To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.

Summit Activities

We have in-licensed Ivonescimab, which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. We plan to initiate phase-III clinical studies in the following NSCLC indications:

Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (HARMONi)

Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (HARMONi-3)

Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies.

Overview of Role:

The CTA is responsible for supporting the daily workflow of clinical operations activities. The CTA provides administrative support to study teams throughout the study. Key administrative activities include, but are not limited to, managing meeting invitations, creating agendas and meeting minutes, study document filing, maintaining study trackers, and oversight of the study-specific eTMF.

Role and Responsibilities:

• Assists and provides support to the members of the clinical operations study team in administrative activities in order to facilitate the overall management of Company sponsored studies

• Executes tasks as assigned by the CPM related to the conduct of clinical studies, study budget forecasting and tracking

• Responsible for ensuring study documentation (including trial master files (TMF), study related contracts and financial level documentation) and study documentation is processed, maintained/archived in compliance with ICH-GCP, Company policy and procedures.

• Be responsible for setting-up, monitoring verifying and archiving the clinical Trial Master File (TMF)

• Manage the clinical study creation and set-up for the country and site binders and the trial milestones.

• Ensure the TMF is being maintained up-to-date and all essential documents are appropriately filed in the TMF.

• Create and update financial information within the Ipsen financial K2 system (Internal Order, Purchase Order, goods receipt & invoices), if not managed by a dedicated position within the team

• Responsible for tracking, collecting and disclosure of expenses in compliance with regulations in force: EFPIA disclosure code (Europe), Sunshine Act (US)

• Ensure the complete data tracking by the CROs with the Data Collection Template (DCT), organize presentation of the instructions to the CROs if needed.

• Check the data received from the CROs with the support of the CRM/CPM

• Responsible for data entry and status updates within the Ipsen Clinical Trial Management System (CTMS)

• Update the eCTMS with the CRO tracker information after validation with the CRM/CPM as per the CTMS user guide (at study, region and site level as applicable

• Coordinate and conduct in-house and external clinical operations activities including generating contract templates within the Ipsen dedicated system (i-CAP), follow-up until the clinical study contracts are signed and secure proper filing and archiving of all fully executed contracts

• Attend all study team meeting when appropriate and take meeting minutes

• Perform any clinical study activity delegated by CRM/CPM such as the project management and monitoring of clinical studies, including liaison with monitors, CROs, drug vendors, central laboratories and other vendors

• Be active member of dedicated working groups to achieve clinical operation excellence and harmonization by updating/revamping processes

Experience, Education and Specialized Knowledge and Skills:

• 2+ Years of Experience in clinical study environment within CRO or Pharmaceutical company.

• Strong understanding of the phases of clinical drug development and clinical operation processes from start-up to close-out.

• Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines

• Ability to organize, prioritize tasks, identify and resolve issues efficiently. Manage multiple tasks effectively and follow through on assigned tasks.

• Ability to receive general instructions on new assignments and perform routine work independently. Collaborate and work effectively within a team and within a multi-disciplinary environment.

• Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form.

• Attention to detail, accuracy and confidentiality.

• Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader) and database software (eTMF, EDC) to support operation of clinical trial databases and electronic filing methods.

• Work in a fast-paced, demanding and collaborative environment.

• Demonstrate high ethical standards for honesty, truthfulness and integrity.

The pay range for this role is $108,336 to $120,242 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with a 15% discount up to the federal limit, flexible spending account among other benefits compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits human resources department to obtain prior written authorization before referring any candidates to Summit.