Clinical Lab Study Manager
Accountable for the delivery of one or more studies from protocol through to study report and archiving. These can be all types of study from First in Human to Phase IV
Accountable for managing the interface between the company, Phase 1 Units, CROs and other vendors to ensure assigned studies are delivered according to contract specifications, with high quality, on time and on budget.
Accountable for leading the internal and Joint Clinical Study team; lead study specific decision-making, develop strategies for increasing study efficiencies and co-ordinate issue detection, resolution and, where necessary, escalation to the Program Delivery Leads.
The level of CPM assigned to a project (either CPM or Senior CPM) will be dependent on study complexity and type (e.g. First in Human studies), scope, size and geography.
Senior CPMs will be accountable for more complex studies and/or those with high visibility such as pivotal trials or challenging POC studies.
STATISTICS (Describe the nature and magnitude of the impact of this role’s decisions and/or actions on the division or function. Cite impact in terms of sales volume, capital expense, project scope, throughput, etc. where possible)
- Sales: N/A
- Budget: Manages study budgets, invoices and monthly accruals owned by project teams, depending on the size and number of studies managed. Ensures efficient and timely execution of clinical trials, with effective cost control.
- Geography (Global / Regional / Local): Global (US/Europe/Asia)
- Other: Position is responsible for decisions affecting the ultimate quality of the product, including regulatory compliance, data quality, patient safety, and investigator relations. Contributes to efficient and timely execution of clinical trials, thereby benefiting cost control, company reputation with future prescribers and patients, and future revenue.
- Lead one or more multi-functional, Clinical Study Team(s) / Joint Clinical Study teams, tailoring the communication interface to ensure effective co-ordination and communication within and across the internal and CRO/Phase 1 Unit teams.
- If a Clinical Pharmacology study, ensure selection of the optimal Phase I Unit within or outside the SPI framework.
- Articulate study scope, goals and expectations of our company to the CRO/Phase 1 Unit at kick-off and ensure they are informed about any relevant sponsor information that may impact the management of the trial throughout the conduct of the trial.
- Creates or contributes to detailed planning of the study, timelines, define critical path to enable seamless access to data, early read out of bioanalytical and safety data to enable data review meetings and early decision making.
- Ensure that the scope, all tasks and responsibilities for a study are appropriately reflected in all study contracts and amendments. Ensure that scope changes are appropriately endorsed and reflected in respective contracts before implementation of activities by the CRO/Phase 1 Unit.
- Review and challenge CRO/Phase 1 Unit strategy and plans, if appropriate.
- Supervise study conduct by regularly reviewing CRO/Phase 1 Unit performance through the review of KPIs, metrics and deliverables, with a focus on critical activities that might delay the project, jeopardize quality, and/or impact budget.
- Ensure a risk assessment is performed and a Risk Mitigation Plan is set-up at the beginning of the study and maintained by the partner CRO.
- Regularly monitor and assess the appropriateness of the risk mitigation plan with the Clinical Study Team(s) / Joint Clinical Study teams and ensure that the cause, impact, remedial actions & preventative steps are assessed for any issues identified to avoid recurrence. Findings, including mitigation plans, to be discussed with the CRO and communicated to all appropriate internal and external stakeholders.
- Familiarize with the competitive landscape; engage with KOLs, investigational sites, patient advocacy groups and other relevant organizations.
- Understand, manage, track and ensure accuracy of study budgets, including the forecast and accrual information.
- Work closely with the Program Delivery Lead, other team members and stakeholders as required and serve as the internal key contact for their assigned studies.
- Closely cooperate with OC&SP and, if applicable, relevant committees/governance bodies and/or CQA regarding the performance and quality of work received from the CROs and other vendors.
- Collaborate with members of Clinical Study Team(s) / Joint Clinical Study teams to develop clinical trial protocols and protocol amendments and study documents by providing input and/or approval as defined in SOPs and, if applicable, Strategic Partnership (SP) documents. Ensure that these documents are appropriately updated, e.g. in case new safety information or other change in scope.
- Support Data cleaning and data evaluation meetings and Results and interpretation meetings (RIMs)
- Support conduct of DMC/safety review meetings
- Ensure that Clinical Study Reports (CSRs) meet the objectives of the trial and correctly reflect the data and the study conduct, in collaboration with the study team members.
- Lead lessons learned meetings as appropriate for assigned studies with internal and CRO team members.
- Ensure quality and adherence to the relevant SOPs, GCP, regulatory guidelines and working practices. Support any audit/inspection activities and support CQA to ensure that result findings from audits/inspections are appropriately addressed in a timely manner.
- Provide study specific training for internal and external (i.e. CRO, vendors, investigators) team members.
- Identify issues/gaps in processes and interfaces with other groups and departments and contribute to developing recommendations for resolution. Contribute to process improvement initiatives, and share best practice experiences with line manager, peers and Partner CROs.
- Visit investigational sites and Phase 1 Units to build and maintain relationships as well as to understand opportunities and challenges to study conduct, including enrollment, when needed for assigned clinical studies.
- Travel including overnight stays- possibly global - required.
- A Senior CPM is expected to mentor other colleagues, present clinical trial related information internally or to an external audience as appropriate.
- A Senior CPM may be assigned to more complex studies and/or those with high visibility such as pivotal trials or challenging POC trials, or multiple studies running in parallel.
- Perform other tasks as deemed necessary by the Company.
- Bachelor's Degree Required
- Master's Degree Preferred
- Ph.D. Preferred
- At least three years’ relevant experience in clinical development including team leadership.
- Experience or capability to manage in-house and/or outsourced regional or global Phase 1, 2 or 3 studies (First in Human to multicenter clinical studies) from study start-up to study report completion.
- A SrCPM must have substantial experience in study management in different indications and proven ability to manage complex multinational studies or multiple simultaneous studies from start to end.
- Clinical trial management in Early and Late Phase and team leadership
- Motivation, mentoring and integration of individuals on multi-functional international teams
- Delivery of scientific/medical presentations and training to both large and small audiences
- Excellent verbal and written communication in English
- Proficiency in the Microsoft office suite
- Good interpersonal skills
- Excellent time management and organizational skills
- Negotiation skills
- Scientific and technical knowledge:
- GCP and regulatory environment
- Medical knowledge and research expertise
- Basic principles of data management and statistics
- Problem solving (Describe the level of “self-starting” thinking required in the for recognizing, analyzing and solving problems)
- Proactive approach, drive and follow through
- Managing multiple concurrent responsibilities in an environment of changing priorities without close supervision
- Ability to handle detailed technical matters and team dynamics
- Reconciliation of conflicting priorities