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Senior Associate, Clinical Trial Specialist

Pfizer


Location:
Cambridge, MA
Date:
10/27/2017
2017-10-272017-11-25
Job Code:
1617193
Pfizer
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Job Details

Job Title Senior Associate, Clinical Trial Specialist

JobID 1617193

Location: Cambridge, MA

Description The Senior Clinical Trial Specialist will work as part of the Early Clinical Development (ECD) organization to assist in the planning, operation and daily execution of healthy volunteer and patient studies to advance the early development portfolio. The Senior CTS brings extensive experience in clinical operations and development that will provide expertise to the training and mentoring of the CTO group. This senior staff member will be a subject matter expert for the group in one of the key areas of the CTO mission. This role will entail working across multiple therapeutic area and project teams. Interfaces regularly with the team's core clinical team as well as colleagues from the study management functions and will be expected to interact appropriately with scientists, external collaborators, and alliance partners along with managing studies and training Clinical Trial Specialists. This position requires onsite location in Cambridge, MA.



**CTO RESPONSIBILITIES**



+ Champion and subject matter expert in area of clinical operations, area of knowledge or regulatory and compliance. W orks collaboratively with scientific/clinical colleagues and stakeholders to share information, best practices, and application of skills/knowledge to maximize project quality.

+ Process owner for internal project(s) that improve clinical operations procedures, training, visibility within the organization, and communication within the CTO group.



**STUDY TEAM RESPONSIBILITIES**



+ Accountable to multiple project/study teams to support the startup, conduct, and close-out of clinical trials (Phase 0, Phase 1 through Phase 2, Proof of Concept).

+ Collaborate with the project team on new study designs, amendments, protocol support and coordinated team review.

+ Develop expertise working with Pfizer clinical checklists and Standard Operating Procedures (SOPs) to ensure compliance with good clinical practice, regulatory agencies, Institutional Review Boards (IRBs), and Pfizer processes.

+ Develop expertise navigating Pfizer compliance systems and registries (e.g. GDMS, pTMF, Clinical Trial Registries, etc.).

+ Assist with the execution and oversight of ongoing clinical studies within the early development portfolio to ensure data collection meets quality standards.

+ Assist in managing and updating all study related documentation (protocols, case report forms, consent documents, and vendor-related forms).

+ Work in conjunction with study operations and clinical lead on devising and executing strategies for study design, enrollment, retention, and compliance.

+ Reviews study start-up documentation including the Study Management Plan, Safety Plan, Trial Master File (TMF), and data collection tools (data fields, edit specifications, and data storage considerations), where appropriate.

+ Reviews data to ensure quality and completeness, including QC review of documents (i.e. IB, Safety Reports etc.)

+ Assist in the collecting and collating of safety data for review meetings

+ Assist with establishing and coordinating IRC meetings.

+ Assist with design, implementation and execution of Digital Medicine and Precision Medicine project plans.

+ May be involved in site selection based on site feasibility and early engagement of collaboration of key partners for select studies.

+ May be involved in study team training of the protocol.

+ Partner with the project clinical team and functional lines (e.g. Global Product Development) to improve ongoing study processes, which may include triage and resolution of site level issues including data quality and study conduct.



**BASIC QUALIFICATIONS**



+ Bachelor's degree in science or related discipline required with at least 3-5 years of clinical trial or research experience as a study coordinator/research assistant or site monitor in industry or academia required.

+ Demonstrated study management / leadership experience.

+ Excellent written and verbal communication and interpersonal skills.

+ Able to handle a moderate volume of highly complex tasks within a given timeline.

+ Detail oriented with strong organizational skills, ability to prioritize, and proactively identify and resolve project-related issues.

+ Possesses technical expertise Word, Excel, PowerPoint, Project to manage study timelines and data flow management for reporting and status purposes.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



+ Travel may be required, ~10%



**ADDTIONAL OFFER DETAILS**



+ **Last Date to Apply for Job: November 5, 2017**

+ **This job is Pfizer Exempt US Grade: 005**

+ Additional Location Information: Cambridge, MA



**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.



**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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