The following current opportunities are available. To apply for a position, please send your resume to careers@gtxinc.com and include the position title within your submission.

Project Manager, Medical Affairs
Senior Clinical Project Manager


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Project Manager, Medical Affairs


POSITION SUMMARY

The Project Manager, Medical Affairs will be responsible for managing all projects that fall under the scope of medical information in accordance with company strategic plans and objectives.


ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Provide leadership, clear direction and deliver with quality on project management deliverables. Ensure cross-functional execution of activities presented in Medical Affairs strategic plans.
  • Work closely with VP, Medical Affairs and Clinical Operations to ensure effective communication, implementation of vision and alignment with overall project management goals.
  • Coordinate activities of the Medical Affairs team including meeting logistics and facilitation and preparation of meeting agendas and minutes to ensure all departmental deadlines are met.
  • Ensure project plan details are accurately captured, documented, accounted for and monitor progress of overall project deliverables. Assist in product publication plan ensuring timely execution.
  • Responsible for managing the established project teams by coordinating input from Medical Affairs, Clinical Operations and Regulatory. Provide formal, written project team status updates, communication and reports updates to all participants.
  • Plan and coordinate the Medical Advisory Board Meetings and investigator meetings.
  • Coordinate GTx, Inc. Medical Team attendance and presentation at scientific meetings.
  • Ensure Medical and Clinical Operation plans and activities are integrated into planning documents and calendars.


EDUCATION AND EXPERIENCE REQUIREMENTS

Minimum Requirements:
Position will require a Bachelor’s degree in Business, Science or related field and a minimum of three (3) years project management experience. Proficient in Microsoft Office programs including powerpoint and excel

Preferred:
Previous pharmaceutical or healthcare experience


KNOWLEDGE, SKILLS AND ABILITIES

  • High proficiency with Microsoft Office applications
  • Excellent verbal and written communication skills
  • Ability to act independently and interact with cross-functional teams to complete complex deliverables
  • Demonstrates a high degree of creativity, foresight, and mature judgment in anticipating and solving project issues
  • Ability to present formally and informally within area of expertise to a diverse set of audiences including senior management
  • Strong organizational skills
  • Strong attention to detail and analytical skills


PHYSICAL DEMANDS

While performing the duties of this job, the employee is regularly required to communicate through talking and listening. The employee is frequently required to stand, walk, sit and use hands and arms to reach and use a computer. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job involve close vision.

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made t enable individuals with disabilities to perform the essential functions.


WORK ENVIRONMENT

The noise level in the work environment is usually quiet to moderate.

 

Senior Clinical Project Manager


POSITION SUMMARY

The Senior Clinical Project Manager (SCPM) oversees the proper implementation, conduct, monitoring, completion and reporting of clinical studies assigned to him/her by their supervisor. The SCPM calculates/tracks study budgets and reports the progress and status of clinical studies to his/her supervisor and other management, as directed. In addition, the SCPM works closely across functions with Clinical Study Monitors, Medical Affairs, Medical Monitor, Data Management/Statistics, Quality Assurance, Drug Safety, Document Control, Regulatory Affairs, and Medical Writing, CROs, and expert consultants, as needed.


ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Provide leadership, clear direction and deliver with quality on project management deliverables. Ensure cross-functional execution of activities presented in Medical Affairs strategic plans.
  • Study Team Leadership - Lead cross-functional study team and/or sub-team, develop, manage and maintain study timelines, minutes, budget and tracking, develop training materials and coordinate training on study procedures, develop study management plan - study specific working practices, develop study execution plans
  • Study Planning - Review and comment on study documents such as synopsis, protocol, ICF and CRFs, develop overall study budgets, recommend number of investigative sites, oversee the development of investigational product supply forecasting and management, input on project specifications and feedback on requirements for CTMS, guide structure and oversee set up of the Trial Master File (TMF)
  • Selection and Evaluation of Investigative Sites - Participate in investigative site selection, identify prospective investigative sites, review feasibility, participate in final investigative sites selection, develop and monitor investigative site budgets and oversee negotiation of financial terms of individual site budgets, manage site payments, monitor GCP/ICH site level compliance
  • Identification and Selection of Vendors - Participate in preparation of RFP, assumptions and SOW, recommend vendors, contribute and review specs for vendors (CROs, IVRS, Labs)
  • Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget
  • Ensure all trial deliverables are met according to timelines, budget, operational procedures and quality standards. Assigned responsibilities can include development of specific sections of protocol and related documents; development of study tools, guidelines and training materials; management of clinical study material; implementation of issue resolution plan; preparation of clinical outsourcing specifications.
  • Preparation of Study Documentation - Review essential regulatory documents, prepare detailed study timeline, develop and oversee risk management plan (e.g. for poor enrollment), prepare, review and approve Monitoring Plan, assure adherence to Monitoring Plan, review eCRF specs (EDC) and review of CRF completion guidelines, design, review and approve study tools (for investigative site use), create study team contact roles and responsibilities, review DM documents (CRO and in-house studies), facilitate Development and Review of Data Review Plan
  • Input on Clinical Database, Safety and CSR Reports - Review edit specifications (paper and EDC), execute EDC User Acceptance Testing (UAT) scripts, facilitate development and review of Clinical Data Review Plan, review Summary Reports, CSR review - appendices and approval, oversight of safety report distribution to investigators, study team and ECs as applicable. Participate in SAE reconciliation
  • Initiation and Site Start Up - Prepare and review material for investigator meeting and CRA Training, conduct CRA training, plan / organize / conduct Investigator meeting, oversight of country regulatory approvals (e.g. CTA, MoH), oversee country / site IRB / EC approval, oversee and/or prepare, review regulatory package (essential documents - blank forms and templates for 1572s, financial disclosure, etc.), review regulatory packages, develop and coordinate materials for investigator meeting, obtain appropriate country/site insurance, authorize investigational product shipment to investigational sites, including (in association with Regulatory) the initial shipment, review and approve informed consent forms (e.g. site or country specific ICFs)
  • Enrollment and Maintenance of Subjects - Ensure enrollment is tracked and recorded appropriately, compile enrollment status, update recruitment strategy, address enrollment and retention issues and be prepared to report this information directly to senior management when requested
  • Follow-Up of Sites, Subjects and Data - Oversight of clinical monitoring to ensure quality data (in-sourced or out-sourced), oversee review and approval of monitoring trip reports, review data as defined by Study Team, schedule and conduct CRA meetings / teleconferences, follow up on outstanding CRFs and DCFs, perform ongoing resolution of subject eligibility, oversee resolution of study conduct issues, address site issues found during audits, support DMC reviews, ensure TMF is current
  • Close Out - Coordinate study close out, coordinate case book preparation, reconcile payments, reconcile study budget, complete all archiving, reconcile TMF


EDUCATION AND EXPERIENCE REQUIREMENTS

Minimum Requirements:
BA / BS Degree in relevant discipline
Minimum 10 years clinical study management experience with at least 2 years direct multinational study management experience

Preferred:
Disease / therapeutic knowledge


KNOWLEDGE, SKILLS AND ABILITIES

  • Excellent oral / written / presentation - solid communications skills
  • Knowledge of ICH/GCP and regulatory guidelines/directives
  • Leadership skills (get it done attitude)
  • Negotiation skills
  • Time management - ability to effectively multi-task and prioritize
  • Financial budgeting and forecasting skills
  • Project management / organizational skills
  • Solid computer skills - requirement of MS applications including (but not limited to) MS Project, Word, Excel
  • Study Tools including electronic system skills - CTMS / EDC
  • Knowledge of drug development process
  • Cross functional and cross-cultural awareness
  • Interpersonal skills and team-oriented


PHYSICAL DEMANDS

While performing the duties of this job, the employee is regularly required to communicate through talking and listening. The employee is frequently required to stand, walk, sit and use hands and arms to reach and use a computer. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job involve close vision.

Performance of tasks essential to this position may require the employee to work directly with, handle, or otherwise come into contact with chemicals, pharmaceutical agents, biological materials or radioactive materials. Personal protective equipment (PPE) such as lab coats, gloves, eye protection or particulate masks may be required.

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


WORK ENVIRONMENT

The noise level in the work environment is usually quiet to moderate.