Senior Project Manager (Midwest or West Coast)

We need to output HTML fragment with sections: About the role? The posting includes "Who are we?" and "Why should you join Avance Clinical?" and "Broad Purpose", "Core Responsibilities", "Qualifications, Skills, And Experience", "What we offer". Also maybe "Departmental Responsibilities" and "Organisational Responsibilities". We need to use

for section headings (e.g., About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). But we can use other headings if they match content? The instruction: "use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It suggests we should use those headings if appropriate, but we can also use other headings? It says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Likely they want us to map sections to those headings where applicable. We need to decide which sections to include based on content. We have content: Who are we? (company description). Why should you join? (culture). Broad Purpose (role purpose). Core Responsibilities (list). Qualifications, Skills, And Experience (list). What we offer (benefits). Also Departmental Responsibilities and Organisational Responsibilities (more responsibilities). Could combine responsibilities into a single Responsibilities section. We should not repeat job title as heading. No Job ID. We must not include boilerplate like EEO etc. There's none. We must not create Pay/Schedule/Benefits sections unless posting actually states them. Benefits: "What we offer" includes list of benefits: Stimulating work, Project diversity, Intellectual challenge, Agile & flexible workplace, Opportunity to progress, Stability, Sense of community, Leadership team..., Flexible work options, Great tools/tech. So we can create a Benefits section. No Pay or Schedule info, so omit those sections. We need to use

• for any list of duties/requirements/benefits. Use

  for prose. We need to preserve all substantive information, not invent or summarize away detail. We need to remove duplicated lines. There's some repetition: "Broad Purpose Avance Clinical is a Contract Research Organisation which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry." This repeats earlier "Who are we?" but we keep both? Might be duplicate; we should avoid duplication. We'll keep unique content. Let's extract sections: - About the company / Who we are: "We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field." - Why join / Culture: "We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success. We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future." - Broad Purpose / Role purpose: "Avance Clinical is a Contract Research Organisation which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry. The Senior Project Manager I (Snr PM I) is responsible for planning and executing clinical trials by coordinating study team members and processes to deliver projects on time, within budget and with the desired outcomes, ensuring the trial is conducted in accordance with the protocol, Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements. The Snr PM I may also line manage a team of Project Associates (PA)." - Responsibilities: combine Core Responsibilities, Departmental Responsibilities, Organisational Responsibilities into a list. We need to list each duty as

• . Must preserve all substantive information; not summarize away detail. So we need to include each bullet point from the responsibilities sections. Let's extract Core Responsibilities bullet points (they are sentences separated by periods). We'll break them into list items. Core Responsibilities list: - Autonomously manage the performance of all aspects of project delivery from commencement to completion, including: - Coordinate the activities of internal and external stakeholders including the sponsor, third party vendors and site staff to execute projects within agreed timelines. - Maintain effective Sponsor communication to proactively manage project timelines, expectations, risks, and issues. - Prepare or review Ethics Committee submission documents, as required. - Develop all study plans and documents to support the effective execution of all Project and Clinical Operations activities. - Identify, evaluate, control, communicate, review and report risks in relation to a project and its critical processes/data. - Ensure protocol deviations are identified, documented, and reviewed in line with study plans. - Review Trial Master File (TMF) documentation to ensure accuracy and completeness as per SOPs. - For a single-site study, oversee and lead the operations of the clinical team, develop the Clinical Monitoring Plan and review Monitoring Visit Reports. - Effectively manage project financial performance of assigned projects, including revenue recognition, forecasting and contract management, sponsor invoicing, site payment management and tracking, vendor payment management and tracking. - Review and/or oversee site budget and clinical trial agreements development. - Review study protocols and other study related documents. - May act as a Lead PM on larger, more complex studies or those involving more than one region. - Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required. - Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements. - Provide guidance and mentoring to less experienced project management staff members and participate in training initiatives. - Other duties as directed by Line Management or delegate in line with skills, experience and/or qualifications. - If Applicable To The Individual's Role, Also Includes Monitor line reports' compliance with use of expected company systems and processes; training completion and timecard entry, leave entitlement administration; and expense processing. - Actively manage the performance of line reports and individual career development strategies. - Support staff retention initiatives, drive staff recruitment (including interviews and probation period management) and manage staff severance. - Manage PA resource assignments across the department in conjunction with the Project Director team, proactively projecting PA resource need. Departmental Responsibilities: - Foster the on-going commitment to maintaining a healthy team culture and promoting good morale, by actively participating in regular Project Management Team meetings. - Maintain effective communication with other members of the department. - Proactively identify risks related to departmental service provision and assist in their mitigation and resolution. - Manage and track business related expenses as per company policy. - Identify training needs of the Project Management Team, provide suggestions for, and support delivery of appropriate training actions and programs. - Assist with the development of departmental SOPs as required. - Participate in internal Quality Assurance activities as required, including responding to audit findings. Organisational Responsibilities: - Embrace the core values of Avance Clinical and endeavor to display those attributes at all times with clients and staff alike. - Commit to Avance Clinical training programs. - Adhere to Avance quality systems. - All staff are required to take reasonable care for their own health and safety and that of other personnel who may be affected by their conduct. - The accountabilities as specified above may be altered in accordance with the changing requirements of the position. We need to include all these as list items. Some are sub-bullets under "Autonomously manage..." but we can flatten. Qualifications, Skills, And Experience: list items. - Bachelor's level degree in life sciences, pharmacy, nursing, or equivalent field. - Previous experience as a PM in a CRO or Pharma company for at least 3-5 years. - Where applicable, previous PM-related line management experience is desirable. - Previous experience as a Clinical Research Associate (CRA) is highly regarded. - Previous training and a working knowledge of ICH GCP and applicable regulatory requirements. - Clear understanding of the requirement to adhere strictly to client confidentiality. - Effective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information. - Demonstrated ability to take initiative in problem solving and in exercising good judgment. - An understanding of Privacy Legislation as it applies to the Clinical Trial Environment. - Ability to work under pressure in a multi-disciplinary team environment. - Willingness to work in, and be supportive of, a positive and dynamic team culture. - Ability to travel (desirable). Very minimal level of travel may be required (up to 10%). What we offer: list items. - Stimulating work - Project diversity - An intellectual challenge - An agile & flexible workplace - Opportunity to progress - Stability - Sense of community - A leadership team that are working together on a common goal - Flexible work options - Great tools / tech to do your job We need to output HTML fragment with

  headings for each section we include. Which sections? About the role? The instruction says use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should map: - About the role: maybe combine "Who are we?" and "Why should you join?" and "Broad Purpose"? But "About the role" could be the role purpose. However we have separate sections: Who are we (company), Why join (culture), Broad Purpose (role purpose). Could combine into About the role? But we also have Responsibilities, Qualifications, Skills, Benefits. We could create sections:

  About the role

  containing Broad Purpose description.

  Responsibilities

  containing list.

  Qualifications

  containing list (maybe combine Skills and Experience). The instruction mentions Qualifications, Skills, Benefits etc. We could have

  Qualifications

  and

  Skills

  separate, but they said prefer a few substantive sections over many thin ones. So combine Qualifications, Skills, Experience into one section maybe titled "Qualifications and Skills". But they gave example headings; we can use "Qualifications" heading and include skills inside. Better: Use

  Qualifications and Skills

  but they said use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we could have separate headings for Qualifications and Skills, but that's many thin sections. They prefer few substantive sections. So we can combine into one heading "Qualifications and Skills". However the instruction says use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but suggests those are typical. I'd follow the spirit: use those headings where appropriate. So we could have:

  About the role

  Responsibilities

  Qualifications

  Skills

  Benefits

  But that's many sections; but each has substantive content. However they said "Prefer a few substantive sections over many thin ones." So maybe combine Qualifications and Skills into one section titled "Qualifications and Skills". But they gave example of Qualifications and Skills as separate headings; but we can still combine. I'll decide to have:

  About the role

  (includes company description, why join, broad purpose)

  Responsibilities

  Qualifications and Skills

  Benefits

  That's four sections. Now we need to output only HTML fragment, no markdown. Let's craft. First, About the role: combine who