MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe. 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

The Sr. Clinical Operations Specialist will act as a key agent for the operational set-up, delivery and close out of clinical trials including assisting with monitoring, day to day management of vendor interaction, and the development of study documents and plans.  This individual will participate in the planning, implementation and general oversight of clinical trial activities in conjunction with the project leader.  Will oversee CROs, contract monitors and bioanalytical labs, manage study activities from start-up through close-out, help to identify, evaluate, and select investigative sites, and track and review patient status including recruitment. 

Responsibilities and Job Duties

Clinical Trial Planning - Provides operational and strategic input prior to commencement of clinical trials that include, but are not limited to: clinical planning tools, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, Investigator selection, systems (e.g., CTMS, IXRS etc), clinical trial related operational manuals, training materials, and various clinical trial plans (e.g., monitoring, risk mitigation, communication etc. plans) site selection and budget planning.   -   Monitoring Activities - Manages clinical monitoring activities and the overall site activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics.  Oversee clinical monitoring (site qualification, site initiation, interim monitoring, clinical trial closeout visits) to ensure integrity, accuracy and accountability of clinical data. Informs Clinical Project Manager and other leadership (as appropriate) on overall clinical trial status and of potential issues/mitigation.  May participate in site visits as needed or accompany junior team members for training purposes Site Management - Communicates with clinical trial sites regarding all logistics including contract agreements, support materials and training and assists in the IRB/EC application process, including review of informed consent / HIPAA forms for conformance to pertinent government regulations. Coordinates set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate country/site insurance.  Develops and coordinates study training for study team, investigational sites, and vendors.   Manages clinical site budgets, investigator payment processes and handles invoices related to projects assigned. Escalates study and team issues to project leader. Vendor Oversight - May participate in the selection of clinical service provider personnel including contractors, and clinical research organizations, and with specification development, and management/oversight of third party personnel.  May Serve as the primary project contact for communication and coordination for the third-party vendors.  Reviews monitoring trip reports and tracks resolution of all action items related to CROs.  Insures that vendors comply with all required standards and raises any issues and/or concerns.  Assists with contract and budget preparation, negotiations and management throughout the trial life cycle  Internal/External Meetings - Organizes and manages internal team meetings, investigator meetings, and other trial- specific meetings as required.   Supports and occasionally leads the development/review of clinical study plans, presentations or project/study-related documents.    Data Listing Review - Performs and may lead in-house review of clinical data listings for completeness and accuracy and escalate issues as needed.  Proactively identifies any potential risks and recommends and implements actions to avoid or mitigate problems while considering the appropriate trade-offs of balancing risks with study deliverables and costs. Trial Master File -  Ensures study regulatory files are collected and inventoried and filed as per MacroGenics requirements Ancillary Supplies – Ensures study materials and supplies are available in a timely manner at the location here needed. Study Management Tools - Responsible for the maintenance and updating of data as appropriate in project management tools including CTMS. Implements and maintains project processes and tracking systems (i.e. Screening and Randomization status) and reports to management

Qualifications

Education

BA/BS or equivalent degree in a scientific discipline or related healthcare field

Experience

At least 5 years of clinical trial experience in a pharmaceutical, biotechnology company or clinical research organization(CRO) Prior experience performing the responsibilities mentioned above Significant clinical operations experience with evidence of increasing responsibility within the biotech or pharmaceutical or CRO industry Experience managing Phase 1, 2, 3 clinical trials

Knowledge, Skills and Abilities

Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is required Ability to work on complex or multiple projects with minimal supervision Possesses critical thinking skills for problem solving Experience conducting multi-national / global clinical trials Needs lateral and strategic thinking capacity to drive the study(ies) and understanding the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines. Solid attention to detail and excellent organization skills Solid interpersonal skills and communication skills (both written and oral) Ability to establish priorities. High sense of urgency Collaborate (interpersonal, relationship management) with the study team, crossfunctional team members and external partners/vendors Demonstrates problem solving skills Demonstrates leadership skills Is self-motivated and adaptable to a dynamic environment Strong working knowledge of clinical trial conduct, EDC systems and IVRS            

Preferred Qualifications

Experience in oncology preferred

Supervisory Responsibilities

None

Additional Information

The annual rate of pay for this position ranges from $106,500 to $165,100. For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company’s discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company’s benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits.

The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Statement 

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.  

Equal Opportunity Employer/Veterans/Disabled 

We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.