1+ months

Study Manager

Hedgesville, WV 25427
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**Role Summary:**

The Study Manager acts as the single point of contact for all responsible studies. The Study Manager has accountability for the study end to end delivery throughout study design, start-up, conduct, analysis& reporting, study close-out, inspection readiness, submission and regulatory defense for one or more studies.

The Study Manager will be responsible for developing timelines and budgets for their clinical studies and leading the execution of these studies according to time, cost and quality targets.

The Study Manager is an expert on the operational delivery of clinical trials and brings that expertise to the design & conduct of clinical studies in alignment with the program and portfolio strategies for the specific category (ies).

The Study Manager lead and manage the core cross functional stakeholder for planning and delivery to the Best-in-Class targets as well as optimal resourcing of the study team(s) and ensuring optimal study team(s) health.

The Study Manager is responsible for monitor site performance using appropriate tools and resources (e.g. metrics, site health, Risk Based Monitoring signals etc.) and takes appropriate targeted action. Conducts risk assessments to identify actions for mitigation and control across studies. And conduct and report oversight activities, both remote and onsite visits according to Pfizer standards.

**Organizational Relationships:**

+ The SM reports to the Study Management Lead.

+ All core study team members (e.g. Clinician, Regulatory Affairs etc. )

+ Within Clinical Sciences & Operations: Clinical Trial Execution, Clinical Development Quality

+ Within Global Product Development: Operations Center of Excellence, Portfolio and Project Management

+ Partners with other functional lines including but not limited to finance, procurement, legal, outsourcing lead, etc.

+ Externally medical and professional bodies.

+ Partners with Feasibility Center of Excellence as needed

**Resources Managed (budget and FTEs):**

+ Manage vendor resources for outsourced studies.

+ Building, forecasting and managing the Clinical Trial Budget

**Responsibilities:** **Across Entire Study:**

+ Accountable for managing overall study timelines, budgets and quality targets

+ Accountable for building, forecasting and managing the Clinical Trial Budget

+ Leads the core study team; manages, facilitates and documents core study team meetings (e.g. meeting agendas & minutes, action logs and decision logs) and facilitates effective decision making

+ Effectively manages and leads external vendors to deliver key clinical operations milestones for

outsourced studies.

+ Oversees CRAs to ensure that protocol and monitoring plan are consistently and appropriately implemented across investigator sites.

+ Proactively identify and resolve study operations-related issues as they arise.

+ Provides clinical timelines and costs for feasibility scenario planning to support Asset Team decision making process

+ Responsible for ensuring that studies are conducted in compliance with GCP, relevant SOPs, and

regulatory requirements; Responsible for inspection readiness for all aspects of the study conduct

+ Share best practices across the organization to ensure cross-line standardization.

+ Support the efficient implementation and utilization of globally agreed, processes, technologies and

strategies (e.g. OC-RDC, Datalabs, IMPALA, etc.) to ensure consistent processes are used across


+ Monitor site performance using appropriate tools and resources (e.g. metrics, site health, Risk Based Monitoring signals etc.) and take appropriate targeted action. Conducts risk assessments to identify actions for mitigation and control across studies.

+ To act as CTM PoC for INSPIRE Site.

**Study Start-up**

**Protocol Development**

+ Provide comprehensive operational input to the protocol design to ensure operational feasibility.

+ Responsible for conducting the protocol feasibility prior to finalization of the CPEs, as appropriate.

+ Generate study level ICD, as appropriate.


+ Provide input to the generation of investigator grant budgets at the study level (identify required

budget components).

+ Initiate, review and ensure approval of the study start-up budget, including per subject and ancillary

investigator costs, and Clinical Trial Budget (or MPA).

**Data Management/GCDS Interactions**

+ Partner with GCDS to ensure set up of data capture tools (CRFs, EDC system, diary cards,

questionnaires, translations etc.) to ensure completion within project deliverable timelines.

+ Overall responsible for ensuring the study has efficient and effective data flows (for all types of study

data, including SAEs, endpoints, patient diaries, lab data, etc).

**Subject Recruitment/Country Allocation/Site Selection/Start-up (as appropriate)**

+ Conduct study level allocation including country and study level feasibility assessments to ensure

appropriate site selection in China.

+ Develop study level recruitment/retention strategy/plan; oversee implementation of plan, including

site-level plans, recruitment/retention tools, and advertising materials.

+ Oversee sites and site management to ensure timely site selection and site readiness (Clinical Site

Agreements, Ethics Committee approvals and regulatory documentation.)

+ Partner with Project Planner and study team members to develop study level plans and processes to ensure alignment with overall Development Plan

**Training/Investigator Meeting (as appropriate)**

+ Develop the Monitoring Plan; ensure sites and CRAs are trained on Protocol-Specific aspects of the Study Monitoring Plan.

+ Responsible for working with Clinician to ensure that CRAs are provided with appropriate training of protocol and knowledge of respective therapeutic area.

+ Drive and/or contributes to investigator meeting strategy/agenda and responsible for overseeing

implementation by the project team; review meeting objectives/materials.

Facilitate and presentation investigator meetings on study progress update and etc., as upon request of project team.

**Drug Supply**

+ Collaborate with Supply Chain Lead to develop and complete the Request for Clinical Supplies.

+ Work with the Supply Chain Lead to ensure that clinical trial drug supplies are ordered, produced,

labeled and supplied in a timely manner.

**Communications and Tracking Deliverables**

+ Track progress to ensure all essential study materials, equipment and documentation are in place for

study start (e.g., ethics and regulatory approval, budget, drug supplies, data collection tools).

+ Provide update of study status to study team as appropriate.

**Clinical Study Conduct**

**Subject Recruitment/Retention**

+ Manage protocol-level subject recruitment and retention and take appropriate action to ensure targets are met.

**Quality & Compliance Management**

+ Periodically review protocol deviations and collaborate with clinicians to manage protocol deviations

according to Pfizer SOP.

+ Works closely with study team to ensure data quality requirements are agreed and met, prior to reporting.

+ Perform required activities to ensure quality and completeness of Trial Master File and any additional

regulatory documentation.

+ Work with quality assurance line to establish appropriate QC, audit and inspection plans. Serves as

central point of contact for site and sponsor audits. Supports the writing of appropriate audit

responses and ensures actions are completed.

+ Leads and oversees the study risk planning process (e.g. IQMP)

+ Oversees operational metrics across study and manages trends and escalations

+ Ensures maintenance and accuracy of Standard Operating Procedures (SOP) log

+ Leads awareness and resolution of Significant Quality Events (SQEs) and escalations

+ Monitors and remediates quality metrics and completes remediation tracker

+ Conduct and report oversight activities, both remote and onsite visits according to Pfizer standards.

**Data Flow Management**

+ Partners with GCDS and site management functional lines to ensure timely retrieval and

database entry of CRFs and other clinical study data and the distribution and resolution of data


+ Coordinates endpoint collection, reconciliation and adjudication, when required.

+ Coordinates data collection and cleaning for interim data locks (e.g., DSMBs, Planned interim

+ analysis, Final Safety Updates, etc)

+ Ensures Quality Gate timing planning, and team readiness

**CRO/Vendor Management**

+ Effective management of external vendors including SMOs and CROs.


+ Compiles components of protocol level budget.

+ Approve up front or initial payments to investigators and vendors.

**Drug Supply**

+ Work with Supply Chain Lead to ensure drug supply (including resupply) process timelines, risks

and issues are handled in a timely manner.

**Communications and Tracking Deliverables**

+ Monitor cross-site performance and raise issues to CRAs for awareness.

+ Responsible for distribution of protocol level to CRAs and then ensure investigational sites are fully informed in timely manner.

+ Manages study team communications to ensure cross-functional connectivity among study team members and supporting functional lines

**Clinical Study Close-out**

+ In close partnership with the CRAs to ensure site closeout activities are completed.

+ Responsible for the collection and consolidation of the Protocol Deviation Logs.

+ Accountable for study close out; support GCDS in database lock and release activities, ensuring all

timelines and quality goals are met.

+ Contributes information regarding study conduct, as required, to ensure effective and timely study

reporting. Participates in review of study report, as appropriate.

+ Responsible for inspection readiness at a study level with site facing activities such as self-inspection remaining the responsibility of the Study Management group.

**Technical Competencies:** **Competency** **Detail / Comments (specific skills, etc.)**

+ Scientific and drug development expertise

+ Clinical study expertise

+ Problem solving/Decision Making

+ Organizational skills

+ Communication skills

+ Project/process management

+ Administrative excellence

+ Clinical/Scientific aptitude

+ Technology management

+ Budget / expense management

+ Understanding of scientific/clinical principles,

and ability to work across different therapeutic

areas. Knowledge of working with complex and

novel emerging technologies, and interpret and

incorporate them within the context of a clinical


+ Extensive knowledge of clinical development

process including in depth knowledge and

understanding of the principles of GCP

+ Ability to understand and influence Site

Investigators/Key Opinion Leaders on non-medical related issues

+ Working knowledge of the principles and

concepts of other disciplines

+ Works independently. Receives instruction

primarily on unusual situations

+ Ability to make complex decisions that require

choosing between multiple options and have

the potential to impact the delivery of the

program/project and resource on the


+ Ability to work in ambiguous situations within

the team to identify and resolve complex


+ Ability to organize tasks, time and priorities of

self and others; ability to multi-task.

+ Ability to communicate effectively and

appropriately with internal & external

stakeholders, locally and globally.

+ Ability to write scientific documents and to be

able to 'translate' these into documents used

for operationalizing clinical studies.

+ Ability to manage studies and processes to

agreed quality and timelines

+ Knowledge of the clinical development

process, understand concepts and principles of

study design, and application to manage and

run studies

+ Attention to detail evident in a disciplined

approach to document maintenance and


+ Extensive depth and breadth of knowledge of

systems/processes related to all aspects of

study conduct to enable crisp study delivery

+ Knowledge/understanding of technologies to

support data acquisition including EDC and

data validation

+ Understands and has ability to efficiently

manage budgets

+ Consistently utilizes industry benchmarking

and performance data

**Behavioral Competencies:** **Competency** **Detail / Comments (specific skills, etc.)**

+ Collaborative, supportive

+ Innovation

+ Influencing

+ Networking and Alliance Building

+ Learning Organization

+ Flexibility

+ Tactical Thinking

+ Teamwork

+ Initiating and Implementing change

+ Customer Focus

+ Work successfully with others to ensure team

effectiveness and demonstrate Pfizer values

+ Explores, implements and utilizes novel,

moderately complex methodologies;

encourages and shares innovative approaches

to build and maintain a competitive advantage

+ Lobbies key internal and external stakeholders

to ensure delivery of study goals

+ Ability to influence study teams and sites

+ Looks for opportunities for collaboration to help

deliver study goals and acts upon them

+ Contributes to a learning environment by

sharing knowledge and best practice within and

across study teams. Mentors other team

members in core discipline.

+ Responds positively and constructively to

changing situations

+ Develops and implements short- and mid-term

study plans to deliver study team goals with

limited support

+ Ability to work independently and

autonomously as well as within a team; shows

respect and support for all team members.

+ Works collaboratively with group members and

contributes to positive intra- and inter-team

relationships both locally and globally; deliver

on commitments to study team and line

+ Advocates and encourages actions that

improve existing approaches and systems.

+ Proactively manages change by identifying

opportunities and coaching self and others

through the change

+ Identifies and builds effective relationships with

customers and other stakeholders.

**Qualifications (Training, Education & Prior Experience):**

+ Minimum of BS/BA in a biomedical discipline or equivalent education/training is required

+ At least 5 years in clinical practices

+ Good working knowledge of Good Clinical Practices (GCPs), monitoring, clinical drug development process and country regulatory environment

+ Experience with clinical research methodology (e.g., study design, study monitoring and data

analysis). Prior study management and/or study coordination experience preferred.

+ Demonstrated effectiveness in working in a multidisciplinary, matrix team situation.

+ Effective verbal and written communication skills in relating to colleagues and associates both inside

and outside the organization.

+ Advanced education and/or training/experience desirable.


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

Posted: 2019-12-05 Expires: 2020-07-09
Sponsored by:
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Study Manager

Hedgesville, WV 25427

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