Eli Lilly and Company

Clinical Trial Manager

Location
Philadelphia, PA, United States
Posted
Mar 14, 2019
Ref
47998
Required Education
Bachelors Degree
Position Type
Full time
Avid Radiopharmaceuticals, Inc. (Avid RP), a wholly-owned subsidiary of Eli Lilly and Company, is a molecular imaging company developing diagnostics and biomarkers that improve global health by accelerating the development of new medicines and enabling a tailored approach to healthcare. For more information, visit www.avidrp.com .

Responsibilities
The Clinical Trial Manager is responsible for the conduct and management of investigational studies in the clinical department. The position will be responsible for identifying, selecting, and closing out appropriate investigational sites for clinical studies. He/she will interact closely with other cross-functional areas involved in Clinical Development and will report directly into the Associate Director, Clinical Program Leader.

Responsibilities:
  • Responsible for the conduct of all investigational studies of Avid's molecular imaging agents, insuring adherence to FDA regulations, ICH GCP guidelines and Avid's internal SOPs
  • Manage all components of clinical trials from protocol inception through CSR completion. Includes staffing, writing and implementing protocols, site selection, designing CRF, data management plans, monitoring plans and training site staff, internal staff and monitors on protocol specific procedures
  • Maintain project timelines during the planning, initiation, ongoing/active and study completion stages of clinical trials
  • Supervise the selection of appropriate investigational centers to expedite the conduct of clinical studies. Conduct site qualification to assess the qualifications and capabilities of potential sites and investigators and conduct site initiation visits;
  • Manage the study budgeting process;
  • Negotiate clinical outsourcing vendor agreements including CRO, Central lab, ECG and electronic data capture as well as manage vendors with respect to contracted scope of work and budget
  • Serve as liaison between clinical operations and other functional areas
  • Design electronic data capture forms to insure proper data collection for all clinical study data
  • Demonstrate a commitment to developing around Avid's core competencies: cultivates innovation, drives engagement, ensures accountability, plans and aligns, nimble learning, and manages complexity
  • Other duties as assigned
47998BR

Basic Qualifications
  • Bachelor's degree required
  • Minimum of 3 years of experience that includes a combination of managing external monitoring and in-house CRA workload and clinical trial management
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position


Additional Skills/Preferences
  • Bachelor's degree in scientific or health care field preferred
  • Strong project management skills with a track record of success
  • Strong CRO management skills with a track record of success
  • Strong knowledge of FDA regulations and ICH guidelines
  • Phase I-IV clinical trials experience, preferably with radiopharmaceuticals, central nervous system or oncology therapeutics
  • Ability to lead, plan and execute various activities with minimal supervision under aggressive study timelines
  • Excellent problem solver with outstanding attention to detail
  • Ability to manage multiple projects with competing priorities
  • Excellent communication skills, interpersonal, and teamwork skills
  • Experience managing global clinical trials preferred
  • Protocol writing, clinical study report writing preferred


Additional Information
  • Must be willing and able to travel within the USA and worldwide 10-25% of time
  • Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.