Project Manager

Linda Solomon

EDUCATION: West Chester State University, Coatesville Hospital School of Nursing

Registered Nurse, 1980

SUMMARY OF THERAPEUTIC EXPERIENCE:

•Pulmonary- efficacy study for asthmatics- Phase IIb, safety and efficacy study in adults and pediatrics

with Cystic Fibrosis- Phase III-US and global-RPS and Genaera. Two Phase 2 studies

(US/Canada and US/Germany) in Cystic Fibrosis and Bronchiectasis

•Infectious Disease- treatment of PCP in AIDS patients- Phase III, antiretroviral therapy in HIV

patients- Phase II, PK/antiviral- Phase I, pediatric antiviral- Phase III-New Drug Services

•Device- study of transport of oxygen via non-invasive device- Phase II-

•Musculoskeletal- osteoporosis- Phase III (3 month contract with Wyeth; Women Health Department

as a Clinical Liaison to Data Management)

•Oncology- photodynamic therapy in cutaneous breast cancer- Phase III, bone metastasis in breast

cancer- Phase III (a 4 year permanent position with New Drug Services as a CRA)

•Rheumatology- multi-dose pharmacokinetics in SLE GN- Phase II, multi-dose pharmacokinetics in

SLE- Phase II, Ascending Dose Tolerance in SLE- Phase I (a 3 year permanent position with

PPD as a Senior CRA than an Associate Project Manager)

•Oncology- chronic cancer pain- Phase IV, photodynamic therapy in Kaposi's sarcoma- Phase III,

bone complications in multiple myeloma- Phase III, pharmacokinetic and safety, advanced solid

tumor- Phase I, ascending dose tolerance in advanced cancer- Phase I, non-small cell lung

cancer- Phase III, prostate cancer- Phase III

•Immunology (Vaccines)- pediatric meningitis- Phase II/III

•CNS- prevention of smoking relapse- Phase III, smoking cessation- Phase IV

•Radiology- safety, dosing, and efficacy study for contrast-ultrasound- Phase II

•Cardiovascular- adult hypertension- Phase III, sealant for patients undergoing cardiothoracic surgery-

Phase II/III

•Ophthalmology- macular degeneration- Phases II and III-US and global, macular degeneration- 2

Phase II studies (neovascular and geographic atrophy), development of nuclear cataract post

vitrectomy Phase II, glaucoma Phase II.

PROFESSIONAL EXPERIENCE:

I3pr to Pharmaaxis, Exton, PA

February 2010 to present (4 month cpntract)

•Direct report to Global Project Manager in UK and Australia

•Develop and maintain clinical SOPs

•Develop new processes and procedures

•Update protocol, informed consent form template, CRFs, source document, review safety reports,

•Manage study start up of multiple full-scope project and ensure vendor(s) compliance for Phase II

trials

•Coordinate project organization, implementation and management activities between all functional

areas and vendors

•Serve as primary vendor/site contact for all project related issues

•Manage CRO functions and their progress along with CRA responsibilities in the global and US

arena

•Manage project plan/timelines and monitor against project progress; ensure project activity

compliance with plan. Suggest and implement alternative solutions to problems with study

timelines, schedules, resources, budgets, etc. Take corrective action where necessary

•Assess resource needs with vendors and establish appropriate project team. Monitor ongoing resource

needs to project

•Ensure appropriate project tracking using computer assisted programs and ensure timely entry of

project information

•Responsible for project profitability

•Report study progress, issues, and scope of work considerations to senior management

•Provide direction supervision, guidance and training to study team while encouraging independence

and refining of their skills

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Linda Solomon

Othera Pharmaceuticals Inc., Exton, Pennsylvania

2007 to 2009

Project Manager, Clinical Operations- for 1 US/Canada and 1 US/Germany study in Cystic Fibrosis

and Bronchiectasis

Acting Study Lead/Assistant Director, Clinical Operations – for 2 US studies in macular

degeneration, 1 US study for the development of nuclear cataract post vitrectomy, 1 US study in

glaucoma or ocular hypertension, and 1 US study in Stargardt’s disease

•Direct report to Director of Clinical Operations and VP of Clinical Operations

•Develop and maintain clinical SOPs

•Develop new processes and procedures

•Write protocol, informed consent form template, CRFs, source document, Study Operations

Manual, develop monitoring tools, write safety narratives, MedWatch forms, assist in the

writing of Clinical Study Reports

•Develop templates for contracts and budgets

•Interview and select new vendors

•Manage study start up of multiple full-scope projects and ensure vendor(s) compliance for Phase II

trials

•Coordinate project organization, implementation and management activities between all functional

areas and vendors.

•Serve as primary vendor/site contact for all project related issues

•Coordinate and implement study training through international investigator meeting, as well as

through US investigator meeting and one-on-one training with vendor staff as needed

•Manage CRO functions and their progress along with CRA responsibilities in the global and US

arena

•Prepare project plan/timelines and monitor against project progress; ensure project activity

compliance with plan. Suggest and implement alternative solutions to problems with study

timelines, schedules, resources, budgets, etc. Take corrective action where necessary

•Assess resource needs with vendors and establish appropriate project team. Monitor ongoing resource

needs to project

•Ensure appropriate project tracking using computer assisted programs and ensure timely entry of

project information

•Develop Project Specific Operating Procedures (PSOPs) with functional areas

•Responsible for project profitability.

•Evaluate and manage project budget against project milestones to ensure project profitability. Take

corrective measures where necessary to keep project in line with budget and profit expectations

•Report study progress, issues, and scope of work considerations to senior management

•Provide input for proposals, assist in project budget preparation/review, and represent project

management services at client presentations.

•Participate in business recruitment and marketing activities. Seek opportunities when appropriate and

communicate these opportunities

•Provide direction supervision, guidance and training to study team while encouraging independence

and refining of their skills

Genaera Corporation, Plymouth Meeting, Pennsylvania

2005 to 2007

Senior Clinical Study Manager – for 2 Global studies and 1 US clinical trial (Cystic Fibrosis and

Age Related Macular Degeneration, Phases II and III)

•Write protocol, informed consent, Study Operations Manual, develop monitoring tools

•Manage study start up of multiple full-scope international projects and ensure vendor(s) compliance

for Phase II and III trials

•Coordinate project organization, implementation and management activities between all functional

areas and vendors.

•Serve as primary vendor/site contact for all project related issues

•Coordinate and implement study training through international investigator meeting, as well as

through US investigator meeting and one-on-one training with vendor staff as needed

•Manage CRO functions and their progress along with CRA responsibilities in the global and US

arena

•Prepare project plan/timelines and monitor against project progress; ensure project activity

compliance with plan. Suggest and implement alternative solutions to problems with study

timelines, schedules, resources, budgets, etc. Take corrective action where necessary

•Assess resource needs with vendors and establish appropriate project team. Monitor ongoing resource

needs to project

•Ensure appropriate project tracking using computer assisted programs and ensure timely entry of

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Linda Solomon

project information

•Develop Project Specific Operating Procedures (PSOPs) with functional areas

•Responsible for project profitability.

•Evaluate and manage project budget against project milestones to ensure project profitability. Take

corrective measures where necessary to keep project in line with budget and profit expectations

•Report study progress, issues, and scope of work considerations to senior management

•Provide input for proposals, assist in project budget preparation/review, and represent project

management services at client presentations.

•Participate in business recruitment and marketing activities. Seek opportunities when appropriate and

communicate these opportunities

•Provide direction supervision, guidance and training to study team while encouraging independence

and refining of their skills

Contracting Services with both Wyeth and Genaera

2005-2005 (3 month contract with Wyeth) then later in 2005 contracted with and accepted a permanent

position with Genaera)

Clinical Operations Liaison to Data management

•Lead Manager of the contracting group; coordinated project organization, implementation and

management activities between the clinical group and the data management group for the

collection and review of CRFs globally

•Coordinated and implemented group tasks for the collection and the review of all data

•Coordinated and implemented the resolution of all issues resulting from the data review

•Prepared the collection timelines and monitored against project progress; ensured the activity was in

compliance with plan.

•Suggested and implemented alternative solutions to problems with study timelines, schedules,

resources, etc. Took corrective action where necessary

•Assessed resource needs with vendors and established appropriate project team. Monitored ongoing

resource needs to project

•Ensured appropriate project tracking using computer assisted programs and ensured timely entry of

project information

•Reported study progress, issues, and scope of work considerations to senior management

•Provided direction supervision, guidance and training to study team while encouraging independence

and refined skills

RPS, INC. (RESEARCH PHARMACEUTICAL SERVICES, INC.). Plymouth Meeting,

Pennsylvania. 2004 to 2005

Project Manager - Asthma Study and Global Project Manager in Cystic Fibrosis

•Assist in the writing of protocols, informed consents and monitoring tools

•Managed multiple full-scope projects from the planning phase to the analysis phase for delivery to

client

•Coordinated project organization, implementation and management activities between all functional

areas and the client. Served as primary client contact for all project related issues

•Prepared the project plan/timelines and monitored against project progress; ensured project activity

compliance with plan. Suggested and implemented alternative solutions to problems with study

timelines, schedules, resources, budgets, etc. Took corrective action where necessary

•Assessed resources needs with functional area managers and established appropriate project team.

Monitored ongoing resource needs to project

•Established appropriate project tracking using computer assisted programs and ensured timely entry

of project information

•Developed Project Specific Operating Procedures (PSOPs) with functional areas

•Responsible for project profitability. Evaluated and managed project budget against project

milestones to ensure project profitability. Took corrective measures where necessary to keep

project in line with budget and profit expectations

•Assessed scope of work against client contractual agreements and initiated change of scope orders

when appropriate

•Conducted monthly project team meetings at a minimum

•Prepared weekly and monthly project status reports for client

•Prepared and presented study material at client meetings and communicate outcomes to project team

•Reported study progress, issues, and scope of work considerations to Senior Management

•Provided input for proposals, assisted in project budget preparation/review, and represented Project

Management services at client presentations. Participated in business recruitment and marketing

activities. Sought opportunities when appropriate and communicate these opportunities

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Linda Solomon

•Provided direction supervision, guidance and training to Project Managers while encouraging

independence and refined skills

•Developed and conducted Project Management training courses

•Evaluated current processes for efficiency and quality and make recommendations for improvement

to coincide with the strategic focus of the Project Management Department and overall

organization

•Assisted in establishing metrics for project progress and evaluated project performance to these

standards

•Assisted with assessing the fiscal aspects of the Project Management Department and make

recommendations for increased profitability

COVALENT GROUP, INC. Wayne, Pennsylvania

2002 to 2004. Held the following positions:

Associate Director, Project Management, March 2003 to March 2004

•Managed execution of project(s), in accordance with contractual obligations, across all disciplines

(e.g., regulatory affairs/operations, field operations, clinical management, data management, etc.)

and provided accurate weekly updates on progress within each discipline

•Managed project team as a cohesive unit of line representatives

•Managed project team meetings efficiently

•Meetings were to be conducted on a regular basis (e.g., bi-monthly) with an agenda issued prior to the

meeting and minutes, with assigned and timed action items, issued promptly after the meeting

•Ensured all project functions were conducted in accordance with Covalent SOPs (or applicable

sponsor SOPs) and all applicable regulatory requirements

•Primary Covalent interface with sponsors on day-to-day basis

•Conducted QC review of all reports sent to sponsor(s) from the various project team members

•Managed contract deliverables. Collaborated with business development in preparing change(s) of

scope when necessary

•Managed project finances including monthly reconciliation of finance/project reports, assessing spend

vs. budget by discipline and milestone status

•Reviewed and approved monthly invoices to sponsor(s)

•Reviewed final draft documents including, but not limited to, protocols, amendments, final study

reports, study monitoring plans, data management plans, TeleTrial specifications and other

project-specific guidelines

•Managed vendors (labs, packaging, etc.) efficiently

•Primary interface with IS for development of TeleTrial specifications and completion of user

validation. Led and managed all aspects of Investigator/Coordinator meetings

•Provided project-specific training to appropriate Covalent staff and/or Investigator site staff

•Develop and maintained project team membership list(s) in accordance with SOP PM 01

•Developed and maintained project binder of project-specific guidelines

•Provided input to the annual performance appraisal for each member of the project team

•Assisted business development in the development of proposals and participated in business

development presentations for new business, as applicable

Associate Director, Clinical Management, December 2002 to March 2003

•Assist in the writing of protocols, informed consents and monitoring tools

•Directed and managed the clinical management group. Provided positive leadership to assure quality,

effectiveness and efficiency in meeting clinical trial requirements for Covalent/client services

•Primary responsibility for study site activity

•Assured close and cooperative interaction with project management and other departments to support

clients and Covalent

•Developed and maintained an in-depth knowledge of each protocol and contract requirements related

to that pool

•Selected investigator sites in cooperation with sponsor and Covalent operations

•Responsible for investigator site, contract negotiations

•Oversaw study site supplies and materials management per protocol and contract. Provided project

specific training to appropriate Covalent staff. Managed investigator/coordinator meetings

•Served as primary contact for investigators/coordinators or project-related

•Prepared, edited, reviewed and approved all Covalent SOPs which involved clinical management and

investigator site management in cooperation with the Covalent quality assurance and compliance

department

•Ensured practice of the clinical management group is in full compliance with GCP and relevant

SOP’s

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Linda Solomon

Senior Clinical Manager, March 2002 to December 2002

•Developed and maintained an in-depth knowledge of each protocol and the contract requirements

related to that protocol. Selected investigator sites in cooperation with sponsor and Covalent

operations, and disseminated site status information to the operations team

•Responsible for study site supplies and materials management per protocol and contract

•Provided project-specific training to appropriate Covalent staff

•Led and managed all aspects of investigator/coordinator meetings and participated in the development

of project-specific training materials and presentations

•Served as primary contact for investigators/coordinators on project-related questions, including but

not limited to: questions & answers on patient eligibility -waiver requests, discrepancy

resolution, site enrollment tracking, qualification scores, TeleTrial coordination, specialist

interface (e.g. – core laboratory management), initiate, tracked and managed investigator

payments

•Served as project-specific coordinator for in-house deliverables required to support site and field staff

activities (e.g. study supplies, study binders)

•Reviewed site visit reports and follow-up letter to ensure that complete, timely reports are generated

that are consistent with the report completion guidelines established in the study monitoring plan

•Participated in regular regional manager/clinical manager meetings to ensure on-going study

deliverables are maintained relative to site activities

•Effectively interfaced with vendors (e.g. Core Laboratory, drug supply) to support study-related

activities

•Additional tasks as assigned

PPD DEVELOPMENT. Blue Bell, Pennsylvania

1999 to 2002. Held the following positions:

Associate Project Manager, February 2000 to February 2002

•Directly assisted the Project Manager or directly performed the function of Project Manger in all

aspects of running the project and managing personnel

•Performed the function of mentored for junior clinical team members and promoted a strong team

approach for assigned projects

•Communicated with client regarding project issues, maintained timelines and overall study specific

troubleshooting for the assigned PM, as well as developed, maintained and tracked study specific

contracts and budgets from study sites

Senior Clinical Research Associate, February 1999 to February 2000

•Responsible for the conduct of clinical studies including protocol development, case report form

design, study specific diaries and trouble shooting enrollment issues, review of regulatory

documents, qualification of potential sites, monitoring study at the investigation site according to

GCPs, study site closeout visit and evaluation of sites, review of data for completeness and

accuracy, assisted data management with cleanup and preparation of final database for an

assigned study, and conducting internal and external audits of clinical trials

•Developed marketing plan and implementation by way of fashioning a database for follow up by

means of attending national ACRP and DIA conferences

•Developed and trained other junior CRAs in the Master File Audit Process, and study specific

training

NEW DRUG SERVICES, INC. Kennett Square, Pennsylvania

1995 to 1999

Clinical Research Associate

•Responsible for the conduct of clinical studies including protocol development, case report form

design, review of regulatory documents, qualification of potential sites, monitoring study at the

investigational sites according to GCPs, study site closeout visits and evaluation of sites, review

of data for completeness and accuracy, assisting data management with cleanup and preparation

of final database for assigned study, and conducting internal and external audits of clinical trials

•Developed marketing plan and implementation by way of fashioning a database for follow up by

means of attending national ACRP and DIA conferences

INSTITUTE FOR HUMAN PHARMACODYNAMICS. Paoli, Pennsylvania

1994 to 1995

Research Nurse/Study Coordinator

•Assisted in recruiting subjects, conducting medical histories and physical examinations

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Linda Solomon

•Prepared doses, administered study medication to subjects, provided EKG and times

chemistry/hematology/LFTs via lab draws, and monitored subjects for AEs/SAEs

OLSTEN KIMBERLY QUALITY CARE. Conshohocken, Pennsylvania

1991 to 1994

Associate Director, Clinical Services

•Supervised a team of professionals and paraprofessional personnel, including RNs, LPNs, home

health aids, physical therapists, speech therapists, and social workers

•Coordinated and managed daily work load of assigned staff. Recruited, interviewed, and selected

team members, in conjunction with staff development associates

•Evaluated individual staff performance relative to job goals and requirements as outlined in the job

description and according to SOPs

•Promoted ongoing development of staff members through joint visits and observation of care

delivery, coordination of staff needs for information and tools necessary to support the learning

process, and supervision of case conferences and documentation requirements relative to client

care

•Promoted/coordinated communication between team members and physicians/care providers to

assure appropriateness of care, and facilitated any necessary changes to the plan of care

•Assured that caregivers submitted their clinical documentation with established company/divisional

standards and that it was complete and accurate for billing and compliance purposes

•Assured compliance with third party regulations through quality assurance review of documentation,

case conferences, and utilization review

•Facilitated assignment orders for ancillary services (therapists and social workers) and assisted with

coordination of disciplines and utilization of community resources

CHESTER COUNTY HOSPITAL. West Chester, Pennsylvania

1990 to 1991

Charge Nurse/Staff Nurse, Surgical/Coronary Care Units

•Responsibilities included thermo dilution catheritization with continued monitoring, ventilator care,

intracranial monitoring and peritoneal dialysis

NEW DRUG SERVICES, INC., CONTRACTED TO LYPHOMED, INC. Kennett Square,

Pennsylvania. 1989 to 1990

Clinical Research Associate

•Participated in a pneumonia study for subjects with AIDS

•Audited in-house case report forms as well as traveled to the study sites to review and resolve safety

issues in reporting AEs, identified problems and developed resolution plans, and conducted

national data verification and clarification research site visits

ALFRED I. DUPONT INSTITUTE OF THE NEMOURS FOUNDATION. Wilmington,

Delaware. 1988 to 1989

Charge Nurse, Pediatric Intensive Care Unit

•Staff nurse/charge nurse in a 16-bed Pediatric Intensive Care Unit

•Assisted in nurse orientation, staff development of new policies and procedures, planning patient

discharge, home placement, and home care

•Rendered pediatric care with ventilator management, hemodynamic monitoring, pulse oxymetry,

ETC02 monitoring, and apnea monitoring

BRANDYWINE HOSPITAL AND TRAUMA CENTER. Coatesville, Pennsylvania

1982 to 1988

Charge Nurse, Pediatric/Adult Intensive Care/Coronary Care/Trauma

•Staff nurse/charge nurse in a 16-bed adult and pediatric unit

•Responsibilities included thermo dilution catheritization with continued monitoring, ventilator care,

intracranial monitoring and peritoneal dialysis, renal dialysis, and trauma

•Acted as air and transport nurse

SUMMARY OF COMPUTER SKILLS:

•Medadata (EDC with Pharmaxis)

•Word

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Linda Solomon

•Excel

•Lotus Notes

•PowerPoint

•Microsoft publisher

•Access

•Track Ware

•EDC (Data Labs)

•MS Project

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